Drugmaker Alnylam wanted to expand approval of its drug Onpattro, but the Food and Drug Administration rejected the application even after an outside...
The Food and Drug Administration delivered a surprising rejection on Monday of an approval application from the drugmaker Alnylam Pharmaceuticals, sending shares of the biotech down 7% in morning trading to $164.62.
An approval in the cardiomyopathy indication could have meant a significant boost to Alnylam sales, which were $1 billion in 2022. Far more patients suffer from ATTR with cardiomyopathy than with polyneuropathy, though questions about Onpattro’s efficacy in the indication have dogged the program, and analysts had muted hopes for the drug’s commercial uptake.
On Monday, Alnylam CEO Yvonne Greenstreet said on an investor call that the company was surprised by the rejection. “The advisory committee voted in favor of patisiran,” Greenstreet said, using the drug’s generic name. “We’re disappointed that the FDA’s decision was not in alignment with the committee’s position.”
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