Alnylam’s Vutrisiran NDA Incorporates Earlier Onpattro Trial In hATTR Amyloidosis Patients
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.
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Keeping Track: US FDA Okays Alnylam’s siRNA Amvuttra, Alopecia Claim For Lilly’s Olumiant; Sierra Submits Momelotinib
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
Alnylam’s Amvuttra To Take Off From Onpattro’s Runway
The company won approval in hATTR amyloidosis polyneuropathy for the RNAi drug, which offers quarterly subcutaneous dosing versus Onpattro’s I.V. administration every three weeks.
AstraZeneca Doubles Down On Amyloidosis With Neurimmune Alliance
The UK major is paying $30m upfront and up to an extra $730m for the rights to Neurimmune’s NI006, which is in Phase Ib trials for the treatment of transthyretin amyloid cardiomyopathy.