6 Biotechs Facing Key FDA Decisions in March
February 27, 2017
By Alex Keown, BioSpace.com Breaking News Staff
NEW YORK – As the calendar turns to March, investors and biotech insiders are waiting for the U.S. Food and Drug Administration to rule on six therapies that will impact the bottom line of the developers, according to an analysis by RTT News.
1. Merck
Merck is hoping the FDA will expand the uses for its anti PD-1 drug Keytruda beyond its approved treatment targets. Merck is hoping the drug will receive an expanded indication for microsatellite instability-high cancer. The FDA is expected to rule on March 8. Keytruda has already been approved for the treatment of metastatic melanoma, metastatic non-small cell lung cancer, and recurrent or metastatic head and neck squamous cell carcinoma, RTT News said this morning. Sales of Keytruda continue to grow, particularly as rival drug Opdivo has lost some market share. Keytruda earned $1.4 billion in 2016, up 148 percent from 2015.
2. Endo International
After abuse concerns for its severe pain-relief drug Opana ER, an opioid agonist, Endo will meet with the Anesthetic and Analgesic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee to discuss those concerns. Company officials will meet with the FDA committee on March 13. RTT said a new anti-crush formulation of the drug was blamed by the U.S. Centers for Disease Control for an outbreak of HIV in Indiana. The new coating led drug abusers to inject the opioid rather than snort it, according to news reports from March 2016. Following the concerns raised, sales of Opana ER declined to $120.05 million from $132.16 million last year, RTT news said.
3. Mylan
Mylan is expecting to hear from the FDA on its generic version of GlaxoSmithKline ’s Advair diskus inhaler on March 28. Sales of Advair have been declining and the drug lost its patent protection in August 2016. Advair generated $4.7 billion in revenue last year.
4. Roche
Roche is also hoping to hear good news from the FDA on March 28 regarding its multiple sclerosis drug Ocrevus. RTT noted the FDA was originally expected to rule on Ocrevus in December 2016, but the company submitted additional data regarding commercial manufacturing, which delayed the FDA rule by three months. Some analysts project the drug could generate between $2.6 and $3.8 billion, RTT noted.
5. Regeneron
Regeneron is looking for the FDA to rule on its severe atopic dermatitis injectable Dupixent on March 29. Dupixent was developed in partnership with France-based Sanofi . The drug is also being explored for additional indications, including asthma, according to RTT.
6. Radius Health
Radius Health is awaiting the FDAs March 30 decision for Abaloparatide-SC for the treatment of postmenopausal women with osteoporosis. If approved, RTT noted that Abaloparatide-SC would be the “first new bone anabolic treatment option in the U.S. since 2002 for postmenopausal women with osteoporosis.”