Remember when Amarin (AMRN) said, a little more than one week ago, that the Food and Drug Administration was “unlikely” to convene an advisory committee meeting to review data on an expanded use of its heart drug Vascepa?

Wrong. On Thursday, Amarin reversed course, announcing that, indeed, the FDA has scheduled a Vascepa advisory committee meeting for Nov. 14. The agency’s deadline for making an approval decision on the heart drug will also likely be extended into late December from Sept. 28, the company said.

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.

  • How come you don’t mention the fda telling the CEO to keep the adcom notification under wraps? What’s up with that? Also didn’t the fda approve the use of mineral oil before the extensive multi year trial that cost amrn millions

  • How come you don’t mention the fda telling the CEO to keep the adcom notification under wraps? What’s up with that?

  • July 31st was less than the 60 days prior to the Sept. 28th review date by the FDA. The FDA is suppose to notify AMRIN about wanting to get an AdCom together to assist them on their decision…..THey didn’t extend that courtesy out of Political reasons…..That;s why AMRIN thought the FDA was going to make this detemination on their own…….

  • I would like to see the SEC do a Forensic Audit on the FDA panel and their family members and acquaintances…Esp. the people that oversee their Blind Trusts….Look at all the options and stocks related to the approvals and Denials by the FDA over the past year…..Follow the Money….I’m sure the SEC would catch a few big fish…..

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

Privacy Policy