US FDA accepts New Drug Application for vutrisiran for the treatment of the polyneuropathy of hereditary ATTR amyloidosis

The submission is based on 9-month results from the Phase III HELIOS-A study, which is comparing vutrisiran (subcutaneous infusion every 3 months) to patisiran (IV infusion every 3 weeks) for 18 months in 164 patients with hATTR amyloidosis with polyneuropathy.

Source:

Biospace Inc.