Will FDA Widen Use For The Vasecpa Fish Oil Pill, After All?

In a surprising development that has revived intense speculation over the fate of Amarin, the FDA has delayed any decision about whether to widen an indication for the Vascepa prescription fish oil pill. The move was expected last Friday and the delay has now triggered intrigue over what appears to be a complex minuet between the agency and the ‘little drugmaker that could.’ In explaining the rationale for the FDA delay, Amarin released a brief statement saying the agency has not disclosed when a decision may be made on the Vascepa indication. But Amarin attributed the delay to its recent appeal of an FDA decision to rescind a so-called Special Protocol Agreement that was reached with the agency for using a clinical trial for that wider indication. The delay is yet another twist in what has been one of the more closely watched biopharma stock stories on Wall Street this year. Investors were captivated by the possibility that Amarin might have been able to market a potential blockbuster amid a heated 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, had 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 a...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs