Amarin Appeals FDA Rescission Of Special Protocol Agreement

File this under ‘best of luck.’ One week after the FDA rescinded a special protocol agreement that Amarin was counting on to significantly widen usage for its Vascepa prescription fish oil pill, the drugmaker has filed an appeal (see page 18). Whether the agency will change its collective mind is unclear, but a reversal is likely to be a long shot, at best. The effort is the latest 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 the drugmaker 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 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, and  Amarin hoped to steal market share from Lovaza, a $1 billion seller for GlaxoSmithKline (GSK). If the clinical effect of combining Vascepa and a statin were to prove beneficial to cardiovascular outcomes, then a drugmaker that inks a deal wi...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs