Whither Amarin? FDA Panel Rejects Wider Use For Its Fish Oil Pill

In a huge setback for Amarin, an FDA advisory committee voted 9-to-2 against recommending broader use of the Vascepa prescription fish oil pill. Specifically, the panel believes the agency should wait for the results of an ongoing outcomes study to determine whether its pill can demonstrate definitive evidence that there are cardiovascular benefits. That study is expected to be completed in 2016.   Although the panelists agreed that Vascepa significantly lowers triglyceride levels, they expressed uncertainty about whether that can translate into fewer heart attacks. "I am wary of approving a drug that has a potential market of tens of millions of people without hard efficacy data," Brendan Everett of Harvard Medical School, who voted against wider use, tells the Associated Press. 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 as many as 36 million people. The meeting had been one of the most widely anticipated events on Wall Street because Amarin (AMRN) is positioning its pill to steal market share from Lovaza, a $1 billion seller for GlaxoSmithKline. And if the clinical effect of combining Vascepa and a statin proves beneficial to cardiovascular outcomes, then a big pharma that inks a d...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs