Amarin takes ap­pli­ca­tion to ex­pand Vas­cepa la­bel to the FDA as M&A chat­ter heats up

Hav­ing un­veiled an un­ex­pect­ed set of heart pro­tec­tive re­sults for their fish oil-de­rived pill Vas­cepa, Amarin is march­ing ahead to ful­fill block­buster ex­pec­ta­tions for its cho­les­terol-low­er­ing drug by sub­mit­ting an ap­pli­ca­tion to ex­pand Vas­cepa’s la­bel to in­clude the re­duc­tion in car­dio­vas­cu­lar risk.

The com­pa­ny sparked a flur­ry of M&A chat­ter af­ter re­veal­ing da­ta from the RE­DUCE-IT study last year — a 25% re­duc­tion in the risk for the first oc­cur­rence of a ma­jor car­dio event, and a 26% re­duc­tion for 3-point MACE, a com­pos­ite of car­dio­vas­cu­lar death, non­fa­tal heart at­tack and non­fa­tal stroke — al­though con­cerns about the im­pact of the min­er­al oil place­bo on the re­sults prompt­ed lin­ger­ing ques­tions. Ear­li­er this month, Amarin de­buted its ex­plorato­ry analy­sis of the tri­al, with re­searchers sug­gest­ing a 30% re­duc­tion in car­dio­vas­cu­lar events com­pared to the place­bo arm.

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