The Food and Drug Administration is convening a panel of experts Thursday to review a new drug to combat treatment-resistant depression from Alkermes (ALKS). The drug, ALKS 5461, is seen as the key to future earnings growth for the company — but it is not without controversy.

It’s likely to be a big day, featuring debate over the opioid-based treatment, messy efficacy data, and a novel clinical trial design that has never before been used to support a drug approval. After chewing over all the data, the experts on the panel will vote on a recommendation to approve ALKS 5461, or not.

Unlock this article by subscribing to STAT Plus and enjoy your first 30 days free!

GET STARTED

What is it?

STAT Plus is STAT's premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond.

What's included?

  • Daily reporting and analysis
  • The most comprehensive industry coverage from a powerhouse team of reporters
  • Subscriber-only newsletters
  • Daily newsletters to brief you on the most important industry news of the day
  • Online intelligence briefings
  • Frequent opportunities to engage with veteran beat reporters and industry experts
  • Exclusive industry events
  • Premium access to subscriber-only networking events around the country
  • The best reporters in the industry
  • The most trusted and well-connected newsroom in the health care industry
  • And much more
  • Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr.

Leave a Comment

Please enter your name.
Please enter a comment.

A roundup of STAT’s top stories of the day in science and medicine

Privacy Policy