- The FDA has indefinitely delayed a ruling on Amarin's (AMRN) request to expand the use of of the company's Vascepa drug, which lowers triglyceride fat in blood. Under the new "ANCHOR" indication, the therapy would be used to treat people who take statins to cut cholesterol and have a high risk of coronary heart disease.
- The FDA was due to issue its verdict today, but the agency put off the ruling as it's still considering Amarin's request to re-instate the ANCHOR Special Protocol Assessment (SPA) agreement. Under the SPA, the FDA had said that the design of an uncompleted Phase III trial was acceptable to support a marketing application to widen Vascepa's use case.
- However, the agency rescinded that SPA in October and initially denied Amarin's appeal over the matter.
- The FDA has also said that it views that appeal as separate from the firm's request to expand the use of Vascepa.
- Amarin shares are +32%. (PR)
FDA delays ruling on expanding use of Amarin's Vascepa; shares soar
Dec 20 2013, 07:25 ET