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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