FDA Approved Drugs: August 2020

The Express Scripts Office of Clinical Evaluation and Policy lists the drugs that were approved by the Food and Drug Administration (FDA) in July 2020. (Estimated Reading Time: ~10 mins.)
FDA Update

Rukobia Approved for HIV

ViiV Healthcare received FDA approval for a new HIV-1 drug, Rukobia (fostemsavir) on July 2, 2020. Rukobia was approved, in combination use with other antiretrovirals, for the treatment of HIV-1 infections in heavily treatment-experienced adults with multidrug-resistant HIV-1 infections failing their current antiretroviral regimen due to resistance, intolerance or safety considerations. Over 1 million individuals in the US are living with HIV, and over 40,000 individuals are newly diagnosed each year. Treatment with combination antiretroviral therapy (ART) has significantly decreased mortality of HIV-1; however, individuals on long-term ART continue to develop resistance to combination therapy. Resistance to ART increases the risk of the HIV-1 infection transforming into AIDS.   Rukobia is a novel oral antiretroviral known as a glycoprotein 120 (gp120) attachment inhibitor. It works by binding to the viral envelope protein, preventing viral attachment and entry into T-cells. The drug will be available in 600mg extended-release tablets with a recommended dose of 600mg orally twice per day. Rukobia is expected to be launched later this month. The approval was granted following Priority Review, Fast Track and Breakthrough Therapy designations. Pricing information is not available at this time. For full prescribing information see here.

Hulio, a Biosimilar to Humira, Approved

The FDA approved Hulio® (adalimumab-fkjp) on July 6, 2020. A biosimilar to Humira® (adalimumab - AbbVie), Hulio is a tumor necrosis factor (TNF) blocker that inhibits inflammation. It is indicated for treating adults who have ankylosing spondylitis, Crohn’s disease, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis (RA) and ulcerative colitis (UC). It also is approved for treating children four years old and older who have polyarticular juvenile idiopathic arthritis (pJIA). A prefilled, 40mg pen device will be available, as will prefilled syringes in both 20mg and 40mg strengths. Following higher and/or more frequent loading doses for some of the conditions it treats, recommended dosing for most adults is 40mg given subcutaneously (SC) once every two weeks. Doses for pJIA are either 20mg or 40mg once every two weeks depending on the child’s body weight. Hulio is not interchangeable with Humira or with the other Humira biosimilars that already are FDA approved - Abrilada(adalimumab-afzb - Pfizer), Amjevita (adalimumab-atto - Amgen), Cyltezo® (adalimumab-adbm - Boehringer Ingelheim), Hadlima (adalimumab-bwwd – Samsung Bioepis) and Hyrimoz (adalimumab-adaz - Sandoz). Under the terms of an agreement with AbbVie, which is similar to settlements with the other Humira biosimilar manufacturers, Mylan and its partner, Fujifilm Kyowa Kirlin Biologics, do not expect to release Hulio in the U.S. until July 31, 2023. Like all TNF inhibitors, Hulio has a boxed warning that outlines the increased risks of cancer and serious infections that may be associated with its use. Prospective patients should be screened for tuberculosis (TB) before starting treatment and periodically while therapy continues. For Hulio’s prescribing information, look here.

Inqovi Approved to Treat Myelodysplastic Syndromes

Astex Pharmaceuticals, a subsidiary of Otsuka Pharmaceutical Company, received approval from the FDA on July 7, 2020, for Inqovi® tablets. It is a fixed-dose combination of 35mg of decitabine, an antimetabolite that has been available as an injectable for about 15 years, with 100mg of cedazuridine, a new cytidine deaminase inhibitor. The first oral formulation of decitabine, Inqovi is indicated to treat adult patients who have specific subtypes of intermediate- and high-risk myelodysplastic syndromes (MDS), including chronic myelomonocytic leukemia (CMML). MDS are a group of cancers that mainly occur spontaneously (de novo) and vary in severity. In smaller numbers, some also can be secondary to other conditions, such as Fanconi anemia, or to previous chemotherapy (chemo) or radiation treatment for other cancers. They attack bone marrow, resulting in abnormal, often nonfunctional red blood cells (RBC), white blood cells (WBC) and/or platelets. According to the Leukemia and Lymphoma Society, about 15,000 new cases of MDS are diagnosed each year in the U.S. Most patients are over the age of 50 and men are slightly more susceptible than women. To treat them, one Inqovi tablet will be taken daily on an empty stomach for the first five days of 28-day treatment cycles. Because it can be used at home, Inqovi will allow patients taking it to avoid the three-hour long IV infusions and the trips to treatment facilities that they needed previously. It is an Orphan Drug that was approved under the FDA’s Priority Review process. In the U.S., Inqovi will be distributed by Taiho Oncology beginning in the first half of August. For its complete prescribing information, please look here.

Upneeq Approved by FDA                       

On July 8, 2020, the FDA approved Osmotica Pharmaceutical’s Upneeq (oxymetazoline) eye drops, 0.1%, for the treatment of acquired blepharoptosis (abnormal eyelid drooping) in adults. Upneeq will be available in a preservative-free solution. Upneeq’s active ingredient is a reformulation of the vasoconstrictor oxymetazoline, a common active ingredient in over-the-counter nasal sprays, which are used to relieve congestion. In the eyes, it works by constricting the Müller’s muscle of the eye, raising the upper eyelid. The recommended dose is one drop into each affected eye once per day. Osmotica estimates around 13 million patients; 50 years old or older, in the U.S. are affected by blepharoptosis, which can affect one or both eyelids, impair peripheral vision and cause a “sleepy” appearance. Common causes include eye surgeries, contact lenses and underlying neurological disorders. Currently, the only treatment option for blepharoptosis is surgery. In clinical trials, the drug met its primary endpoints measured by a statistically significant improvement in Leiscester Peripheral Field Test (LPFT), a visual field test. The drug also showed a statistically significant improvement in Marginal Reflex Distance (MRD-1), a test to show improvement in the upper eyelid margin. The drug was well tolerated with the most common adverse events (AEs) being dry eyes and redness of the eyes. Osmotica is launching the drug in August through a new subsidiary called RVL Pharmaceuticals, which will market and dispense exclusively through their fully owned and operated pharmacy. The company is using a cash-only model, in a direct-to-consumer pricing and dispensing strategy, at a cost of $3 to $4 per day, with discounts for a three-month supply. The product will be available as 0.3mL single-use containers in 15- or 30- count cartons. For full prescribing information see here.

New Pediatric Indications Approved for Dysport and Botox

In the United States, an estimated three children per 1,000 have cerebral palsy, which is impaired motor functioning caused by brain malformation or brain damage before, during or right after birth. Symptoms, which range from mild to disabling, include loss of balance, poor coordination and weak muscle tone. Patients often experience related conditions such as difficulty breathing, hearing loss, seizures and vision problems. Botulinum toxins decrease muscle activity by temporarily blocking nerve impulses. All botulinum toxin products, which are not interchangeable, must be injected by medical professionals who are trained in their use. They all have Medication Guides and boxed warnings that they may drift away from the areas where they are injected -- possibly causing widespread side effects, such as muscle weakness and vision changes. Rarely, serious breathing or swallowing problems can occur. Drifting and side effects can happen even several months after the product has been injected. Children may be especially prone to having adverse effects.

Ipsen Pharmaceuticals received FDA approval on July 8, 2020, for Dysport® (abobotulinumtoxinA) to treat both upper limb and lower limb spasticity from all causes, including cerebral palsy, for children at least two years old. Due to an Orphan Drug exclusivity issue, Dysport did not previously have approvals for all symptoms of cerebral palsy. For spasticity in the arms, its recommended pediatric dose for each arm is eight Units to 16 Units/kg or a maximum of 640 Units; for each leg, the dose is 10 Units to 15 Units/kg up to a maximum of 1,000 Units. Each total dose is divided into smaller injections that are administered in several sites of each muscle. Treatments should be separated by at least three months. Also indicated for adults who have cervical dystonia (uncontrollable contractions of neck muscles), Dysport has a cosmetic indication for adults who have lines between the eyes, as well. Here is updated prescribing information for Dysport.

Also on July 8, 2020, Botox® (onabotulinumtoxinA - Allergan) was FDA approved to treat children as young as two years old who have spasticity in their lower legs due to cerebral palsy. To treat it, the pediatric dose is four Units to eight Units/kg of the child’s body weight given as one Unit to two Units/kg injected into two separate sites in each affected muscle at the back of the calf. No more than eight Units/kg or 300 Units should be used for any one treatment and doses should total no more than the lower of 10 Units/kg or 300 Units in any 90-day period. In addition to several cosmetic uses, Botox has multiple other medical indications, including as a treatment for adults who have cervical dystonia, eyelid/eye muscle spasms, migraine and overactive bladder. For complete prescribing information, check here.

Second Indication for Tremfya

Tremfya® (guselkumab - Janssen) is an interleukin-23 (IL-23) inhibitor first approved in 2017 to treat adults who have psoriasis. It gained an additional FDA indication on July 13, 2020, as the first drug in its class for treating psoriatic arthritis (PsA). By blocking a key cytokine, it interferes with inflammation and the immune process. PsA affects approximately 1.5 million patients -- about three out of every ten U.S. adults who also have psoriasis. In addition to the skin plaques typically caused by psoriasis, PsA is associated with pain in the joints – particularly in the hands, feet, hips, shoulders and spine. For both of its indications, Tremfya’s recommended dose is 100mg, available as single-dose prefilled syringes and One-Press auto-injectors for SC use. The first injection is followed by a second four weeks later, then one every eight weeks thereafter. To treat PsA, Tremfya can be used alone or with a non-biological disease-modifying anti-rheumatic drug (DMARD), such as methotrexate. Here is its revised prescribing information.

New Qutenza Indication

Qutenza® (capsaicin – Averitas Pharma) 8% patch was given a new indication on July 17, 2020. It now is approved to relieve peripheral neuropathy of the feet for adult patients who have diabetes. For the new use, up to four patches will be applied to the patient’s feet in a well-ventilated treatment facility and by a trained healthcare provider using appropriate protection, such as nitrile gloves and a face shield. Patches may be cut to fit the size and shape of the painful areas, which must be pretreated with a topical anesthetic before the patches are applied. Left in place on the feet for no more than 30 minutes, Qutenza patches are believed to deactivate pain receptors. However, many patients experience temporary pain or burning related to the patches. Treated areas also may be more sensitive to heat for few days after treatments. For most patients, side effects can be managed with ice packs and oral pain medications. Treatments, which should be at least three months apart, also may cause brief episodes of hypertension, so blood pressure will be monitored during therapy sessions. Qutenza’s original FDA approval was in 2009 for postherpetic neuralgia (PHN) — pain that persists after an attack of shingles. Here is its complete prescribing information.

MedWatch Update: Hand Sanitizers

During the summer, the FDA has issued a series of warnings that multiple commercial hand sanitizers contain methanol and it has asked a number of manufacturers to recall their products. Also known as wood alcohol, methanol is intended for industrial use in products such as pesticides and solvents. It has no medical uses, and it never should be ingested. If it is absorbed through the skin or consumed, methanol can cause dangerous acid buildup in the blood. Immediate symptoms of methanol poisoning can include blurred vision, confusion, dizziness, drowsiness, headache and nausea. Not all individuals exposed to methanol have symptoms, however. People who think they may have signs of methanol poisoning or who think they may have been exposed to methanol should talk with a doctor right away. Prolonged extensive contact with or consumption of methanol can lead to serious side effects, such as blindness, coma, seizures and death. The FDA has received reports of deaths, including some among children who drank a hand sanitizer by accident, associated with some of the products being recalled. It reminds the public that frequently washing hands with soap and water for at least 20 seconds is the best way to prevent the spread of disease. If hand sanitizers are used, they should contain 60% or more of ethanol (also called ethyl alcohol). Many of the recalled products are labeled as ethanol, so people who have hand sanitizers should check the FDA’s website for the brand name of the product. Recalled products containing methanol should not be put into the trash or flushed down the drain. Individuals who have them can call the local Poison Control Center or their pharmacy for directions on how to dispose of them. For more information, including a list of the affected products, see the FDA’s notice.

Recall: Metformin Extended-Release Tablets

Beginning on May 28, 2020, the FDA has asked several manufacturers of generic metformin extended-release tablets to recall some or all lots of their products due to contamination. Some of the tablets contain amounts of a potentially cancer-causing chemical, N-nitrosodimethylamine (NDMA), that are above the levels considered acceptable by the FDA. Metformin is a common treatment choice for patients who have type 2 diabetes. No brand-name or immediate-release metformin is being recalled; and not all the extended-release forms are affected. Check here for additional information about the recalls and here for the FDA’s Q&A page.

Wynzora Wins FDA Approval

MC2 Therapeutics received approval from the FDA on July 20, 2020, for its topical product,  Wynzora®(calcipotriene/betamethasone dipropionate) 0.005%/0.064% cream. The combination of a vitamin D analogue and a corticosteroid, it is indicated to treat plaque psoriasis for patients at least 18 years old. Directions are to coat affected areas with the cream once a day until plaques clear up. No more than 100g should be used per week and Wynzora should not be used continually for more than eight weeks. It is not to be used for sensitive regions, including the armpits, face and genital area. Brand and generic calcipotriene/betamethasone are available in the same strength as a topical foam, ointments and suspension; however, Wynzora is the first cream formulation. It is not interchangeable with any other product. Its launch date and pricing plans have not been released. Full prescribing information can be found here.

Xywav Approved to Treat Narcolepsy

On July 21, 2020, the FDA approved Xywav (calcium, magnesium, potassium and sodium oxybates) oral solution from Jazz Pharmaceuticals. Intended to treat cataplexy (sudden loss of muscle tone, but not consciousness) and excessive daytime sleepiness (EDS), it is indicated for patients who are at least seven years old and who have narcolepsy. A successor to Xyrem® (sodium oxybate – Jazz), Xywav has 92% less sodium (approximately 1,000mg and 1,500mg less per night) than Xyrem. For patients transitioning from Xyrem, the starting dose of Xywav is the same as the Xyrem dose. For patients new to treatment, doses begin at 4.5g/night – divided into one 2.25g dose at bedtime and a second one at two and one-half to four hours later. Xywav doses may be increased by 1.5g/night on a weekly basis until the target maintenance dose of 6g to 9g/night, divided into equal parts, is reached. Both doses must be diluted with about one-fourth cup of water in separate designated containers and placed within easy reach of the patient, who should take each dose while in bed and then lie down after dosing. Like Xyrem, Xywav is a C-III controlled substance. Both carry boxed warnings that they are central nervous system (CNS) depressants, which may interfere with breathing. Additionally, both products may be abused or misused. With launch planned by the end of 2020, Xywav will be distributed through the Xywav and Xyrem Risk Evaluation and Mitigation Strategy (REMS) that requires prescribers and dispensers to be trained and certified. Patients must be enrolled in the REMS program before they receive Xywav, as well. Here is prescribing information for Xywav.

MedWatch Update: Naloxone

In a Safety Communication on July 23, 2020, the FDA alerted prescribers, pharmacies and patients of a new requirement for opioid drugs. It is directing drug companies that make opioids for pain relief and for use in treating opioid use disorder to add information on the labels about the use of naloxone. As emergency treatment for opioid overdoses, naloxone blocks breathing problems that can cause death from overdoses. Several doses may be needed to control an overdose, but naloxone is not a substitute for emergency medical help. Even if it is used to reverse an overdose, 911 should be called and medical attention given to the patient. The FDA suggests that health professionals who prescribe opioids discuss naloxone with patients and provide prescriptions for those who might be at risk for overdoses. Some states allow pharmacies to dispense it without a prescription. Patients and their caregivers should be trained in how and when to use naloxone, and patients should carry it with them. Please see the FDA’s notice for more information.

Tecartus Approved for Mantle Cell Lymphoma

Kite, a subsidiary of Gilead, received approval from the FDA on July 24, 2020, for Tecartus (brexucabtagene autoleucel) for the treatment of adult patients who have relapsed or refractory mantle cell lymphoma (MCL). A type of B-cell non-Hodgkin lymphoma (NHL), MCL affects lymph nodes, causing them to grow and releasing cancer cells into the blood and lymphatic systems. Often diagnosed in advanced stages, it tends to spread quickly and resist treatment more than some other forms of lymphoma. The American Cancer Society estimates that MCL accounts for about 5% of B-cell lymphomas or around 3,800 new cases in the U.S. per year. Most often diagnosed after the age of 60, it affects more men than women. Tecartus is a chimeric antigen receptor (CAR)-T cell therapy that is administered as a one-time IV infusion. It  has boxed warnings that using it may be associated with cytokine release syndrome (CRS) and/or neurological problems. Serious CRS, a potentially severe inflammatory response that can cause organ dysfunction, affected around 18% of patients in clinical trials. About 37% of trial participants experienced serious neurological effects such as encephalopathy (disrupted mental status), headache and speech disturbances. Tecartus is the first CAR-T cell therapy approved for MCL. Other CAR-T cell therapies on the market include Gilead’s Yescarta®(axicabtagene ciloleucel), which is approved to treat certain diffuse large B-cell lymphomas (DLBCL), and Novartis’ Kymriah® (tisagenlecleucel), approved for some DLBCL and for certain acute lymphoblastic leukemia (ALL). While a date has not been released, Kite plans to launch Tecartus at a drug cost of $373,000.  Under a REMS shared with Yescarta, Tecartus will be dispensed and administered solely through specifically certified hospitals. Providers and staff members will have specialized training to treat patients receiving it and also to recognize and manage potential side effects. The approval was granted under the FDA’s Breakthrough Therapy and Priority Review processes. For full prescribing information, look here.

Breztri Aerosphere Approved

The FDA approved AstraZeneca’s Breztri Aerosphere (budesonide/glycopyrrolate/formoterol) on July 24, 2020. A combination metered-dose inhaler containing a corticosteroid, a long-acting muscarinic antagonist (LAMA) and a long-acting beta2 agonist (LABA), it is indicated as maintenance therapy for chronic obstructive pulmonary disease (COPD). In clinical trials, Breztri Aerosphere was significantly more effective in preventing moderate or severe episodes of COPD than comparator treatments that included two of its components (24% fewer flares than glycopyrrolate/formoterol and 13% fewer than budesonide/formoterol). Recommended dosing is two oral inhalations every morning and two more each evening. It will be supplied as 120 inhalations per inhaler. No information has been released yet for its pricing or launch. Look here for its prescribing information.

New Treatment for Head Lice

Xeglyze™ (abametapir) lotion, 0.74%, was FDA approved on July 24, 2020. A one-time topical treatment for head lice, it can be used for children as young as six months old. Enough Xeglyze to thoroughly saturate the hair and cover the scalp should be rubbed into dry hair, left on for 10 minutes and then washed out with plain water. Dead lice and their eggs (nits) can be removed with a fine tooth comb. Clothes, bedding and towels that may have come in contact with lice should be washed in hot water, as should hairbrushes, combs and other objects possibly carrying lice or nits. It will be dispensed in seven-ounce bottles. Any Xeglyze that is not used should be left in the tightly-capped bottle and put into the trash or a drug collection box, but it should not be flushed down the drain. Presently, the manufacturer, Dr. Reddy’s Laboratories, is seeking marketing partners for a U.S. launch date that has not yet been determined.  Check here for full prescribing information.

Ortikos Launched

Ferring Pharmaceuticals announced the release of Ortikos™ (budesonide) extended-release capsules to the U.S. market on July 29, 2020. FDA approved in June 2019, Ortikos is a corticosteroid indicated to treat mild to moderate Crohn’s disease that affects the ileum and/or ascending colon. It can be used as active treatment for patients at least eight years old and as maintenance (up to three months) for adult patients. Available in 6mg and 9mg strengths, Ortikos is taken once each morning. It is not interchangeable with any other oral budesonide product. Doses vary according to the age and weight of the patient and the activity of the disease. The recommended eight-week treatment courses can be repeated if Crohn’s disease flares occur. Patients taking Ortikos should not eat grapefruit or drink grapefruit juice while taking it. Here is its prescribing information.

Stelara Receives Indication for Pediatric Psoriasis

Stelara® (ustekinumab - Janssen Biotech) injection was FDA approved on July 29, 2020, to treat children between the ages of six and 12 years who have moderate to severe cases of plaque psoriasis that may be treated with systemic or phototherapy. An inhibitor of two interleukins (IL-12 and IL-23), it helps to decrease the inflammation that contributes to autoimmune conditions such as psoriasis. The National Psoriasis Foundation estimates that about 20,000 children younger than 10 years of age are diagnosed with plaque psoriasis annually in the United States. For children, doses are based on weight and given as SC injections with the second dose four weeks after the first and subsequent doses 12 weeks apart. Although patients or their caregivers can be trained to give Stelara at home, doses for children who weigh less than 60kg (about 130 pounds) have to be measured precisely and drawn into syringes for injection, so children should be treated by healthcare providers in an appropriate setting. Stelara also has FDA approval for treating adults who have psoriatic arthritis or an inflammatory bowel disease. Because it affects the immune system, using it may increase the risk of infections and certain types of cancer. Patients should test negative for tuberculosis (TB) before starting and during its use. Revised prescribing information is here.

Recall: Desmopressin Nasal Sprays

Ferring Pharmaceuticals and its partner, CSL Behring, have issued global recalls for all lots of their desmopressin nasal sprays, DDAVP® (NDC# 55566-2500-000), Stimate® (00053-6871-00) and Amring Pharmaceuticals’ authorized generic (69918-0501-05). Testing of samples found significantly higher-than-specified levels of desmopressin and benzalkonium chloride (a preservative). The risk of a desmopressin overdose or a reaction to benzalkonium could be increased. Potentially, blood levels of sodium could become too low, causing vague symptoms such as confusion, fatigue and nausea. Patients who use one of the recalled products are advised to contact their healthcare providers for an alternative treatment. Desmopressin has several FDA-approved indications that include bedwetting, central diabetes insipidus, hemophilia and von Willebrand’s disease. For more information, please look here for the FDA’s notice.

New Combination of Drugs Approved to Treat Melanoma

On July 30, 2020, the FDA approved using three of Genentech’s cancer drugs – Tecentriq® (atezolizumab) injection, Cotellic® (cobimetinib) tablets and Zelboraf® (vemurafenib) tablets – together to treat advanced melanoma that has mutations in BRAF V600. Cotellic, a MEK1/2 inhibitor, and Zelboraf, a BRAF inhibitor, already were indicated to treat patients who have melanoma with the mutation as identified by diagnostic testing. Tecentriq, a programmed death receptor-ligand 1 (PD-L1)-blocking antibody, increases the immune system’s ability to attack cancer cells. Adding it prolonged the average progression-free survival (PFS) time by more than three months for participants in the key clinical trial (15.1 months) compared to 10.6 months for patients taking Cotellic and Zelboraf while given a placebo IV. Treatment will be on 28-day cycles with the first being 60mg of Cotellic once a day and 960mg of Zelboraf twice a day for the first 21 days, followed by seven days of only Zelboraf 720mg twice a day. Tecentriq then is administered as an 840mg infusion once every two weeks with the doses of Cotellic maintained at 60mg/day on days 1 through 21 of each cycle and Zelboraf at 720mg twice every day. Treatment continues until melanoma worsens or the patient can no longer tolerate the drug side effects. Tecentriq has several other indications that include some bladder, breast, liver and lung cancers. The new indication was approved under Priority Review and Project Orbis, the FDA’s program for sharing information with international drug regulatory organizations to expedite the approval of oncology therapies. Check here for Tecentriq’s prescribing information, here for Cotellic’s and here for Zelboraf’s.

Monjuvi Approved for Second-Line Treatment of Diffuse Large B-Cell Lymphoma

MorphoSys received approval from the FDA on July 31, 2020, for Monjuvi® (tafasitamab-cxix) for injection. A CD19-directed monoclonal antibody, it is approved for use with Revlimid® (lenalidomide – Celgene) capsules for treating patients whose diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma,  has returned or has stopped responding to prior treatment and who are not candidates for stem cell transplants. To treat DLBCL, Monjuvi will be administered at 12mg/kg by IV infusion on 28-day cycles. For the first cycle, infusions will be given on the first, fourth, eighth, fifteenth and twenty-second days. Then, infusions will be administered on days one, eight, 15 and 22 for the next two cycles. On all successive cycles, Monjuvi will be infused on only the first and fifteenth days. Revlimid is stopped following 12 cycles, but Monjuvi continues until the cancer recurs or the patient cannot tolerate the drug’s side effects. Monjuvi disrupts cancer cells by blocking CD19 antigens on the surfaces of B cells. In clinical trials of its use, 55% of patients responded to treatment with Monjuvi and Revlimid – including 37% who had complete responses. The average length of response was 21.7 months. MorphoSys and Incyte will market Monjuvi jointly in the U.S. They anticipate a launch in early August at an estimated wholesale acquisition cost (WAC) of $198,000 for the first year of treatment for a patient weighing approximately 75kg (about 165 pounds). After the first three cycles, monthly WAC will be about $13,000. Monjuvi’s approval was granted under the FDA’s Accelerated Approval, Breakthrough Therapy and Fast Track pathways. For its full prescribing information, please look here.

Spravato Gains Second Indication

On July 31, 2020, the FDA granted an additional indication to Janssen’s Spravato® (esketamine) nasal spray. In combination with an oral antidepressant, it now is approved to treat adult patients who have major depression and who have expressed suicidal thoughts or exhibited suicidal actions. In clinical studies, symptoms of depression began to decrease within four hours for some participants treated with the combination of drugs. Spravato originally was FDA approved in March 2019, along with an oral antidepressant, for adults who have depression that is not managed by other antidepressants. It is a C-III controlled substance intended to be distributed under a REMS directly to certified treatment centers that have specially trained providers. Although patients administer their own doses of Spravato, they are supervised during each treatment and then their blood pressure is monitored for a minimum of two hours afterward. A boxed warning, the REMS and a patient Medication Guide caution that Spravato is sedating, that it may cause changes in perception and that it may be abused. Using it actually may cause suicidal feelings for some patients, as well. Recommended dosing for the new indication is 56mg (four sprays) on the first day, then either 56mg or 84mg (six sprays) two times a week for the rest of a four week period. If the patient is responding, Spravato can be continued at 56mg or 84mg once a week for four more weeks and then at 56mg or 84mg once a week or once every two weeks – whichever is the lowest dose and least frequent timing to maintain relief of depression. For complete prescribing information, please look here.

Epidiolex Receives New Indication

The FDA approved Epidiolex® (cannabidiol – GW Pharmaceuticals) on July 31, 2020, to treat patients who are at least one year old for seizures caused by tuberous sclerosis complex (TSC). At the same time, the previous Epidiolex indications to treat seizures associated with Dravet syndrome (DS) or Lennox-Gestaut syndrome (LGS) also were extended to children as young as one year old. Even though all three conditions are rare, TSC affects about 50,000 patients in the U.S. Usually, it causes non-cancerous tumors in body organs, including in the brain. TSC can produce different types of seizures at varying degrees of severity. Pediatric patients who have it also may be on the autism spectrum, have attention deficit hyperactivity disorder (ADHD) and/or suffer from intellectual disabilities. Adults who have TSC are more likely to be anxious or depressed than individuals who do not have the disorder. More than one-half of patients eventually have seizures that cannot be controlled by currently available anticonvulsant drugs. To treat TSC, the recommended initial dose of Epidiolex is 2.5mg/kg twice each day for one week, then increased by 2.5mg per dose on a weekly basis until reaching the maintenance dose of 12.5mg/kg twice daily. Here is its full prescribing information.

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