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Monthly News Roundup - February 2018

Gilead’s Biktarvy Cleared for Use in HIV-1 Infection

In February, the FDA approved Gilead's Biktarvy (bictegravir, emtricitabine and tenofovir alafenamide, or BIC/FTC/TAF), a combination, once-daily, oral treatment for HIV-1 infection in adults. Biktarvy is used for the treatment of two HIV groups: either those who have no antiretroviral treatment history or those who are virologically suppressed on another HIV regimen for at least three months. In four pivotal studies, Biktarvy effectiveness was shown not to be worse than the active controls (primary endpoint of non-inferiority) at 48 weeks. The most common side effects were diarrhea (6%), nausea (5%), and headache (5%) Biktarvy is expected to compete with ViiV Healthcare’s Juluca (dolutegravir and rilpivirine).

Erleada: A First for Non-Metastatic, Castration-Resistant Prostate Cancer

Using a novel endpoint, the FDA approved Janssen’s Erleada (apalutamide) for the treatment of prostate cancer that has not spread (non-metastatic), but that continues to grow despite hormone treatment (castration-resistant). Erleada blocks androgens that promote tumor growth. This approval is the first to use the endpoint of “metastasis-free survival” (MFS), measuring the length of time after starting treatment that tumors did not spread in the body or that death occurred. In Phase 3 studies, the median MFS for patients taking Erleada was 40.5 months compared to 16.2 months for patients on placebo. Common side effects include fatigue, high blood pressure, rash, diarrhea, nausea, and weight loss, among others.

FDA Approves Symdeko for Cystic Fibrosis With Certain Gene Mutations

Symdeko (tezacaftor/ivacaftor and ivacaftor) from Vertex Pharmaceuticals is now FDA-approved to treat the underlying cause of cystic fibrosis (CF) in patients 12 years of age and older. Specifically, Symdeko is used in those who have two copies of the F508del mutation in the CF transmembrane conductance regulator (CFTR) gene or who have at least one mutation that is responsive to tezacaftor and ivacaftor (Kalydeco). In Phase 3 studies, patients treated with Symdeko had significant improvements in lung function with a favorable safety profile, and results were sustained for up to 48 weeks. The most common adverse events included lung infections and cough.

Osmolex ER OK’d for Parkinson’s Disease, Drug-Induced Movement Disorders

This month the U.S. Food and Drug Administration (FDA) approved extended-release Osmolex ER (amantadine hydrochloride) from Osmotica Pharmaceutical for treatment of Parkinson's disease and drug-induced extrapyramidal reactions in adults, similar indications approved for immediate release amantadine. The once-daily tablet is a unique formulation of immediate-release and extended-release amantadine. The effectiveness of Osmolex ER is based upon bioavailability studies that compared Osmolex ER to immediate-release amantadine. The most common adverse reactions reported in 5% or more of patients at the recommended dosage of immediate-release amantadine were nausea, dizziness, lightheadedness, and insomnia.

Benzhydrocodone/Acetaminophen (Apadaz) Approved for Short-Term Pain

KemPharm’s Apadaz (benzhydrocodone/acetaminophen) has been FDA-approved for the short-term (14 days or less) management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Apadaz is an immediate-release combination of the prodrug benzhydrocodone and acetaminophen. When ingested, stomach enzymes cleave the prodrug (benzhydrocodone) and release the active parent drug (hydrocodone). The approval of Apadaz via the 505(b)(2) pathway was based in part on pharmacokinetic studies with Vicoprofen, Ultracet, and Norco. In clinical programs, Apadaz did not demonstrate abuse-deterrence by measurement standards. Apadaz will be scheduled as a C-II controlled substance product.

Long-Acting Ocular Corticosteroid Dexycu Cleared for Cataract Surgery

Cataract surgery is a procedure to remove the cloudy lens of the eye and, in most cases, replace it with an artificial lens to improve vision. The FDA has now approved Dexycu (dexamethasone) from Icon Bioscience Inc., a long-acting, injectable corticosteroid formulation injected once into the posterior (rear) chamber of the eye for the treatment of postoperative inflammation (swelling) after cataract surgery. One advantage with Dexycu is that patients, who are often older, would not need to self-administer medicated eye drops several times daily over a period of weeks after eye surgery.

Posted: February 2018