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Monthly News Roundup - August 2016

FDA Approves Erelzi: Sandoz’s Biosimilar For Enbrel

A third U.S. biosimilar has been FDA-approved; this time it’s Erelzi (etanercept-szzs), a biosimilar to Amgen’s tumor necrosis factor (TNF) blocker Enbrel. Sandoz’s Erelzi is the first approved biosimilar for etanercept, and is used for the same five indications found on the reference product Enbrel: rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis. It’s important to note that Erelzi has been approved as a biosimilar, not as an interchangeable product. Physicians must write the prescription specifically for Erelzi, as pharmacists cannot automatically substitute Erelzi for Enbrel. Other approved US biosimilars are Sandoz’s Zarxio (filgrastim-sndz) and Pfizer’s Inflectra (infliximab-dyyb).

Troxyca ER: Pfizer’s Severe Pain Drug Clears FDA

Development of abuse-deterrent pain medications are one tactic encouraged by U.S. public health officials to help combat the opioid abuse epidemic. The U.S. Food and Drug Administration (FDA) has approved Pfizer's Troxyca ER capsules (oxycodone hydrochloride and naltrexone hydrochloride), an abuse-deterrent, extended-release, narcotic. Troxyca is used for severe pain requiring daily, around-the-clock, long-term opioid treatment for which other medications are inadequate. Troxyca ER contains pellets of the opioid oxycodone with a naltrexone core that acts as an opioid antagonist. The naltrexone remains sequestered unless the capsule is crushed, chewed or dissolved.

Sustol: A New Long-Acting Agent for Chemo-Induced Nausea and Vomiting

Acute and delayed chemotherapy-induced nausea and vomiting (CINV) can be a side effect that alters cancer treatment timing and may affect a patient’s outcome. In response, the FDA has approved Heron Therapeutics' Sustol (granisetron), a long-acting, injectable 5-HT3 antagonist for the prevention of CINV due to certain cancer treatments. Sustol has a polymer-based drug delivery system to maintain therapeutic levels of granisetron for 5 days or longer, covering both the acute and delayed phases of CINV. In studies, common side effects included injection site reactions, constipation, fatigue, headache, diarrhea, stomach pain, insomnia, and dizziness.

Flonase Sensimist is GSK’s Latest Rx-to-OTC Switch

For many of us, allergies tend to go year-round. In August, the FDA approved a new over-the-counter (OTC) product, Flonase Sensimist (fluticasone furoate, 27.5 mcg spray) Allergy Relief, from GSK Consumer Healthcare. Flonase Sensimist, available as Veramyst in prescription form, is an OTC corticosteroid nasal spray indicated for the treatment of symptoms associated with seasonal and year-round allergies in adults and children ages 2 years and older. GSK expects to commercially launch OTC Flonase Sensimist in early 2017.

Merck’s Keytruda Approved for Advanced Head and Neck Cancer

The immune checkpoint inhibitor group of medications has been a breakthrough development in advanced, metastatic cancer treatment. In August, the FDA approved another new use for Keytruda (pembrolizumab), a PD-1 (programmed death receptor-1)-blocking antibody that belongs to this group. In addition to treatment of metastatic melanoma and metastatic non-small cell lung cancer (NSCLC), Keytruda can now be used for recurrent or metastatic head and neck squamous cell carcinoma with disease progression on or after platinum-containing chemotherapy. The approval is based on data from the KEYNOTE-012 study, with responses of six months or longer observed in 82 percent (n=23/28) of patients.

Posted: August 2016