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Alnylam Pharmaceuticals Files Supplemental New Drug Application With FDA for Vutrisiran
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Alnylam Pharmaceuticals Files Supplemental New Drug Application With FDA for Vutrisiran
Oct 10, 2024 10:06 PM

08:59 AM EDT, 10/09/2024 (MT Newswires) -- Alnylam Pharmaceuticals ( ALNY ) said Wednesday it has submitted a supplemental new drug application with the US Food and Drug Administration for vutrisiran, which is intended for the treatment of ATTR amyloidosis with cardiomyopathy.

The FDA had approved the drug candidate for the treatment of polyneuropathy of hereditary ATTR amyloidosis in adults.

The application with the FDA was based on data from a phase 3 study that showed favorable effects of vutrisiran on outcomes of death and cardiovascular events, functional capacity and quality of life.

The company said it used a Priority Review Voucher to expedite the review process.

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