FDA Casts Doubt on Alnylam Drug Trial Results for Expanded Usage

Onpattro’s effects compared to a placebo “were small, of questionable clinical meaningfulness, and may not be detectable by patients,” the US Food and Drug Administration wrote in documents posted Monday ahead of a meeting with Alnylam and expert advisors later this week. There were no major safety issues identified.

A group of FDA advisors will meet Wednesday to discuss evidence from the small trial submitted by Alnylam to support Onpattro’s use in improving symptoms from a specific type of cardiomyopathy that’s also caused by the build-up of amyloid protein in the heart, which can lead to heart failure. The FDA will likely make its decision on whether to approve the drug’s expanded usage by early next month.

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