FDA ad­comm votes in fa­vor of Al­ny­lam's new in­di­ca­tion for On­pat­tro

The FDA’s Car­dio­vas­cu­lar and Re­nal Drugs Ad­vi­so­ry Com­mit­tee on Wednes­day vot­ed 9-3 in fa­vor of Al­ny­lam Phar­ma­ceu­ti­cals’ On­pat­tro (patisir­an) on whether its ben­e­fits out­weigh its risks for the treat­ment of AT­TR car­diomy­opa­thy.

Pan­elists agreed that the mag­ni­tude of On­pat­tro’s ben­e­fit in this in­di­ca­tion was small, but the risks were even small­er.

Ad­comm mem­ber Ed­ward Kasper of Johns Hop­kins School of Med­i­cine said he based his “yes” vote on the fact there’s a “light wind” for ben­e­fit and “no wind” for risk. David Cel­la, pro­fes­sor at North­west­ern Uni­ver­si­ty Fein­berg School of Med­i­cine, al­so vot­ed in fa­vor and not­ed lim­it­ed ben­e­fits but said that he hopes clin­i­cians will coun­sel pa­tients on this op­tion.

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