BRIEF—Alnylam submits vutrisiran for EU approval

USA-based RNA interference (RNAi) specialist Alnylam Pharmaceuticals has formally submitted for European approval to market vutrisiran for certain people with hereditary transthyretin-mediated (hATTR) amyloidosis.

hATTR amyloidosis is a rare, rapidly progressive, and fatal condition.

Alnylam vice president Rena Denoncourt said: “If approved, we believe that vutrisiran will provide an important new subcutaneously administered, once-quarterly treatment option for patients, with the potential to reverse manifestations of the disease in hATTR amyloidosis patients with polyneuropathy.”

The submission is backed by positive nine-month results from the HELIOS-A Phase III study, which met the primary and all secondary endpoints.

A parallel submission in the USA is under review, with a decision expected by April 14, 2022. Filings in Brazil and Japan are also planned for 2021.