An FDA advisory committee gave a 9-2 thumbs-down for expanding the indication for Amarin’s fish-oil product Vascepa. The drug is currently approved for patients with severe hypertriglyceridemia, and the company is seeking to expand its patient reach to include patients with elevated triglycerides as well.
The advisory panel says the agency needs more information before it could consider a new indication.
Forbes notes that the panel had two issues with the data it was given. First, the placebo upped LDL levels in patients, and members had to go back and review the data before deciding that the placebo was biologically inert and OK to consider.
Then, they split on the question of whether the drug’s impact would qualify as a significant clinical benefit, and said they want to wait until results from the company’s REDUCE-IT trial are in. This study is expected to close in 2016.
Jefferies analyst Thomas Wei wrote in his Thursday research note that the panel’s decision was a “Major Negative” for the company. Wei writes that the delay increases competition from generic Lovaza in 2015. Wei puts the value of Vascepa at $1 per share if the drug fails to get an expanded indication.
