FDA Rescinds Special Protocol Agreement For Amarin Fish Oil Pill

In yet another blow to Amarin, the FDA has rescinded a special protocol agreement that the drugmaker was counting on to widen usage for its Vascepa prescription fish oil pill, according to a filing with the US Securities and Exchange Commission. The disclosure comes two weeks after an FDA advisory committee voted 9-to-2 against recommending broader use until an outcomes study is completed in 2016. The decision by the FDA may finally put to rest what has been one of the more interesting stock stories in the biopharma universe this past year. Investors were captivated by the possibility that the company might market a potential blockbuster amid a swirling debate over the virtue of using lower triglycerides as a predictive metric for lowering cardiovascular risks. As we reported previously, Vascepa is already approved for treating people with very high triglyceride levels, or more than 500 mg/dL, which is approximately 4 million people in the US. Amarin, however, has sought FDA approval to market Vascepa to people with high cholesterol and high triglycerides, which is between 200 and 500 mg/dL, a market that is estimated to be as many as 36 million people. The Vascepa approval had been based on a trial called Anchor that was the basis for the special protocol agreement, or SPA, with the FDA. These agreements, of course, reflect close coordination between a drugmaker and the FDA and, while never a guarantee of product approval, generally inspire significant confidence that the ag...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs