06:57 AM EDT, 06/09/2025 (MT Newswires) -- Alnylam Pharmaceuticals ( ALNY ) said Monday the European Commission approved Amvuttra for treating wild-type or hereditary transthyretin amyloidosis with cardiomyopathy in adults.

The company said the decision makes Amvuttra the first RNAi therapeutic authorized in the EU for this form of the disease.

The approval was based on the Helios-B phase 3 study, which showed reduced mortality and cardiovascular events, and improvements in walking distance, heart failure symptoms, and quality of life, Alnylam said.

The treatment, administered quarterly by injection, works by reducing transthyretin protein production at its source, the company added.

Alnylam also said side effects reported were similar to placebo, with injection site reactions and slight liver enzyme increases.