EMA — authorised 29 May 2024
- Application: EMEA/H/C/005493
- Marketing authorisation holder: Biogen Netherlands B.V.
- Local brand name: Qalsody
- 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.
- Pathway: exceptional circumstances, orphan
- Status: approved
On 29 May 2024, the European Medicines Agency (EMA) granted marketing authorisation for Qalsody, a treatment for adults with amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 (SOD1) gene. This authorisation was granted under the exceptional circumstances and orphan drug pathways. Qalsody is developed by Biogen Netherlands B.V. and will be marketed under the local brand name Qalsody.