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Alnylam’s Vutrisiran NDA Incorporates Earlier Onpattro Trial In hATTR Amyloidosis Patients

 
• By Bridget Silverman

Alnylam’s second NDA for an RNA interference treatment for the rare disease rests on a comparison of vutisiran patients in the Phase III HELIOS-A study against an external control arm of placebo patients from Onpattro’s APOLLO study.

Alnylam building
• Source: Alamy

Alnylam Pharmaceuticals Inc. expects a decision from the US FDA in early 2022 on the NDA for vutrisiran, the company’s second RNA interference therapeutic targeting production of transthyretin protein for treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.

Vutrisiran is “complementary” to Alnylam’s Onpattro (patisiran), Alnylam president-R&D Akshay Vaishnaw told a 19 April 2021 conference call that announced the NDA submission

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