The European Commission Approves Alnylam's AMVUTTRA

Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY) is one of the 13 Biotech Stocks with Huge Upside Potential. It declared on June 9, 2025, that AMVUTTRA® (vutrisiran) has been approved by the European Commission to treat wild-type or hereditary ATTR amyloidosis with cardiomyopathy (ATTR-CM).

As a result, AMVUTTRA is the first and only RNAi treatment approved in the EU for transthyretin amyloidosis symptoms that show as cardiomyopathy and polyneuropathy. The HELIOS-B Phase 3 research, which revealed a 36% mortality reduction over 42 months and a 28% decrease in all-cause mortality and recurrent cardiovascular events, served as the basis for the approval.

More than 6,000 patient-years of safety data support the quarterly administration of the medication. The drug is already authorized in Brazil and the United States.

Up to 100,000 individuals in Europe have ATTR amyloidosis, mostly as cardiomyopathy. An RNAi treatment called vutrisiran provides continuous knockdown by stopping TTR production at its source with quarterly injections.

Functional and quality-of-life gains were validated by the HELIOS-B trial, which involved patients on SGLT2 inhibitors and tafamidis. Elevations of liver enzymes and injection site responses are frequent adverse effects.

Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY) is an innovator in the investigation of RNA interference medicines.

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