Alnylam Pharmaceuticals (ALNY) said Monday its RNAi therapeutic vutrisiran, aimed at treating wild type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy, has received a positive opinion recommending approval from the Committee for Medicinal Products for Human Use of the European Medicines Agency.
The opinion was based on phase 3 test results that showed the benefits of the drug on outcomes of mortality and cardiovascular events, as well as functional capacity, health status, and quality of life, on patients with the disease, the company said.
Alnylam said it plans to proceed with additional global regulatory submissions for Vutrisiran, which received approvals from the US Food and Drug administration and the Brazilian Health Regulatory Agency this year.
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