Amarin CEO John Thero discussing the company's plans for Vascepa, August 2019 — via Bloomberg

Amarin wins a block­buster ap­proval from the FDA. Now every­one can shift fo­cus to the patent

For all those peo­ple who could nev­er quite be­lieve that Amarin $AM­RN would get an ex­pand­ed la­bel with block­buster im­pli­ca­tions, the stress and anx­i­ety on dis­play right up to the last minute on Twit­ter can now end. But new, press­ing ques­tions will im­me­di­ate­ly sur­face now that the OK has come through.

On Fri­day af­ter­noon, the FDA stamped its land­mark ap­proval on the in­dus­tri­al strength fish oil for re­duc­ing car­dio risks for a large and well de­fined pop­u­la­tion of pa­tients. The ap­proval doesn’t give Amarin every­thing it wants in ex­pand­ing its use, los­ing out on the pri­ma­ry pre­ven­tion group, but it goes a long way to do­ing what the com­pa­ny need­ed to make a ma­jor splash. The ap­proval was cit­ed for pa­tients with “el­e­vat­ed triglyc­eride lev­els (a type of fat in the blood) of 150 mil­ligrams per deciliter or high­er. Pa­tients must al­so have ei­ther es­tab­lished car­dio­vas­cu­lar dis­ease or di­a­betes and two or more ad­di­tion­al risk fac­tors for car­dio­vas­cu­lar dis­ease.”

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