Biogen Reports Health Canada’s Acceptance of New Drug Submission for Tofersen to Treat Amyotrophic Lateral Sclerosis
Shots:
- Health Canada has accepted for review the company’s New Drug Submission (NDS) of tofersen to treat amyotrophic lateral sclerosis (ALS) associated with SOD1 gene mutation. The decision is anticipated in 2025
- The NDS was supported by the data from 28-wk. P-III (VALOR) clinical evaluation for determining the safety & efficacy of tofersen vs PBO in patients with weakness attributable to ALS and SOD1 mutation
- Tofersen, an antisense oligonucleotide, has previously received the US FDA’s accelerated approval & CHMP’s positive opinion for SOD1-ALS. The EC’s decision for marketing authorization across the EU is anticipated in Q2’24
Ref: Newswire | Image: Biogen
Related News:- Biogen and Ionis Receive the US FDA’s Approval of Qalsody (tofersen) for the Treatment of Amyotrophic Lateral Sclerosis
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
