STAT+: Alnylam drug wins FDA approval for progressive heart disease

The FDA cleared Alnylam’s therapy for the heart disease ATTR-CM, setting the company up to compete with drugs from BridgeBio and Pfizer.

Mar 20, 2025 - 23:00
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STAT+: Alnylam drug wins FDA approval for progressive heart disease

The Food and Drug Administration has cleared Alnylam Pharmaceuticals’ treatment for a progressive heart condition Thursday, setting it up to compete with therapies from BridgeBio and Pfizer.

Alnylam’s drug, vutrisiran, was approved for patients with transthyretin amyloid cardiomyopathy, or ATTR-CM, to reduce cardiovascular-related death and hospitalizations. This indication was widely expected among investors and is similar to the indications given for competing therapies.

The treatment, which will be sold under the brand name Amvuttra, was additionally approved to reduce urgent heart failure visits.

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