Will An FDA Panel Recommend The Amarin Fish Oil Pill?

Will an FDA advisory panel recommend a wider indication for a prescription fish oil pill without an outcomes study to demonstrate the treatment can reduce the risk of cardiovascular events? This question, which is one of the more controversial unknowns to captivate biopharma investors for the past few months, will be answered on Wednesday when a committee meets to review Vascepa. Here is the background: the pill 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, hopes to win 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 FDA deliberation is being closely watched because Amarin is positioning its pill to steal market share from Lovaza, a $1 billion seller for GlaxoSmithKline. If the clinical effect of combining Vascepa and a statin proves beneficial to cardiovascular outcomes, then a big pharma that inks a deal with - or simply acquires - Amarin, has a blockbuster on its hands. What remains unclear is whether the FDA would require an outcomes study before granting approval. An 8,000-patient study called is under way, but results will not be known until 2016. And late last week, the FDA released briefing documents that suggested a slightly higher degree of uncertainty. Why? Here is what FDA clinical reviewer Mary Dunne Robert...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs