Biotech firm Amarin Corporation (NASDAQ: AMRN) had a positive start to the week, with the shares making sharp gains and hitting the highest level in more than a decade. Though initially there was speculation as to where the stock is headed, the rally gathered momentum towards the end of the week after an FDA committee unanimously voted in favor of label expansion for Vascepa, the company’s flagship medication made from fish-oil. The stock traded up 14% on Friday afternoon.
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The market has been abuzz with debates on the efficacy of Vascepa in treating cardiovascular diseases in high-risk patients, as an additional indication. Though experts are divided in their opinion on expanding the label for Vascepa, it is believed that the FDA panel‘s favorable stance has cleared the decks for the drug to reach millions of cardiac patients. The majority of the panel members recommend that the label be expended for atherosclerotic cardiovascular disease groups.
It’s been more than a year since Amarin came up with the path-breaking finding, pursuant to an extensive clinical trial, that Vascepa is effective in reducing conditions like stroke and heart attack, without compromising on patient safety. Then, the market responded positively and the stock made sharp gains. Though the FDA needs to take all the related factors into consideration before approving the label expansion, it will give due importance to the committee’s recommendation.
In the meantime, the bullish sentiment surrounding the latest event is expected to fuel the stock’s rally, extending it into the coming weeks. Experts believe that several millions of new patients in America will be using Vascepa following the label expansion, though there is no clarity yet on the drug’s target market.
Once approved, Vascepa will be prescribed to cardiovascular patients with a high risk of heart attack and currently receiving other forms of therapy. Some analysts are of the view that Amarin might find it difficult to serve the potential market, considering its huge size, which might prompt the management to pursue co-promotion deals with other pharmaceutical companies.