Qalsody (tofersen)
OrphanExceptional circumstancesAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- tofersen
- Company
- Biogen Netherlands B.V.
- Status
- Authorised
- Therapeutic area
- Amyotrophic Lateral Sclerosis
- CHMP opinion
- Thu 22 Feb 2024
- EU approval
- Wed 29 May 2024
- Designations
- Orphan, Exceptional circumstances, Additional monitoring
- Application
- EMEA/H/C/005493
- ATC
- N07XX22
- Official record
- www.ema.europa.eu
Indication
Qalsody is indicated for the treatment of adults with amyotrophic lateral sclerosis (ALS), associated with a mutation in the superoxide dismutase 1 (SOD1) gene.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.