Trial Profile

Escalating Dose and Randomized, Controlled Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy

Status: Completed

Phase of Trial: Phase II/III

Latest Information Update: 04 Jul 2025

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At a glance

27 Jun 2025 Results presented in the Biogen Media Release.
23 Jan 2025 According to Biogen media release, the USFDA has accepted the company's supplemental New Drug Application (sNDA) and the EMA has validated the application for a higher dose regimen of nusinersen for SMA, based on data from this study, which have shown that higher dose regimen of nusinersen has meaningful clinical benefits while maintaining a safety profile similar to the approved 12 mg regimen. These applications are now under review in the US and Europe.
06 Nov 2024 According to Biogen media release, the company plans to file applications for the 50/28 mg higher dose nusinersen regimen with global regulatory agencies.

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