Amarin emerges from an ex­pert pan­el re­view with a clear en­dorse­ment for Vas­cepa and high odds of suc­cess when the FDA weighs in for­mal­ly

Sev­er­al FDA ex­perts who gath­ered Thurs­day to con­sid­er the land­mark ap­proval of Vas­cepa to re­duce car­dio events in an at-risk pop­u­la­tion voiced their un­ease about var­i­ous as­pects of the ef­fi­ca­cy and safe­ty da­ta, or ul­ti­mate­ly the pop­u­la­tion it should be used to treat. But the over­whelm­ing be­lief that the da­ta point­ed to the drug’s ben­e­fit and clear­ly out­weighed risks car­ried the day for Amarin.

The pan­el vot­ed unan­i­mous­ly (16 to 0) to sup­port the com­pa­ny’s pos­i­tive da­ta pre­sen­ta­tion — back­ing an OK for ex­pand­ing the la­bel to in­clude re­duc­ing car­dio risk. The vote points Amarin $AM­RN down a short path to a for­mal de­ci­sion by the FDA, with the odds heav­i­ly in its fa­vor. Chances are the rest of the ques­tions about the fu­ture of this drug will be hashed out in the la­bel’s small print.

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