November 14, 2019 / 9:13 PM / a month ago

FDA panel unanimously backs expanding use of Amarin's heart drug Vascepa

Nov 14 (Reuters) - A panel of experts to the U.S. FDA on Thursday recommended allowing Amarin Corp Plc’s fish-oil derived drug to be used as add-on therapy for reducing the chance of heart attacks and strokes in high-risk patients with cardiovascular disease.

The panel voted 16-0 in favor of expanding approval, potentially opening up a multi-billion dollar opportunity for the company which has only one drug, Vascepa, in the market.

Vascepa, a highly purified omega-3 fatty acid derived from fish oil, won U.S. approval in 2012 to lower high levels of triglycerides — a type of blood fat that can increase the risk of heart disease.

The Food and Drug Administration is not mandated to follow the recommendation of the panel, but generally does. (Reporting by Saumya Sibi Joseph and Trisha Roy in Bengaluru; Editing by Shounak Dasgupta)

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below