Alnylam Onpattro’s Expanded Use Gets Weak Thumbs Up From US FDA Panel

 
• By Sarah Karlin-Smith

A restrictive label could be the result of the lukewarm endorsement from the majority of the agency’s Cardiovascular and Renal Drugs Advisory Committee for use of Onpattro for the treatment of ATTR-associated cardiomyopathy.

baseball player bunting
Two FDA advisors described Alnylam’s Onpattro ATTR cardiomyopathy data as a 'bunt single' in lukewarm positive panel. • Source: Shutterstock

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