Alnylam’s vutrisiran Fast Track’d for rare inherited nerve disorder

The FDA grants Fast Track status for Alnylam Pharmaceuticals’ (NASDAQ:ALNY) RNAi therapeutic vutrisiran for the treatment of adults with polyneuropathy (damage to multiple peripheral nerves) of hereditary transthyretin-mediated (hATTR) amyloidosis, a rare inherited disorder in which a protein called amyloid builds up in organs and tissues causing the loss of sensation in the limbs, feet and hands.

Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the marketing application.

Topline data from a Phase 3 study, HELIOS-A, should be available in Q1 2021.

https://seekingalpha.com/news/3560415-alnylams-vutrisiran-fast-trackd-for-rare-inherited-nerve-disorder