Alnylam's Onpattro: Not Following FDA Guidance Amplifies Clinical Meaningfulness Concerns

 
• By Sarah Karlin-Smith

Even if Alnylam can get a favorable advisory committee vote and is able sneak out an approval for Onpattro for ATTR-associated cardiomyopathy, its lack of data on hard clinical outcomes makes it unlikely to unseat Pfizer’s tafamidis for the rare disease.

image of the heart (organ)
FDA advisors will vote on a supplemental indication for Onpattro for the treatment of ATTR cardiomyopathy 13 September. • Source: Shutterstock

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