Qalsody
What Qalsody is used for
Qalsody is indicated for the treatment of adults with amyotrophic lateral sclerosis (ALS), associated with a mutation in the superoxide dismutase 1 (SOD1) gene.
Approved use, as published by the European Medicines Agency.
What the labels mean
- Orphan medicine: for a rare disease (affecting no more than 5 in 10,000 people in the EU).
- Approved under exceptional circumstances: full data cannot be collected, usually because the disease is very rare.
Key facts
- Brand
- Qalsody
- Active substance
- tofersen
- Disease area
- Amyotrophic Lateral Sclerosis
- Medicine group
- Other nervous system drugs
- ATC code
- N07XX22
- Marketing authorisation holder
- Biogen Netherlands B.V.
- Authorised in the EU since
- 2024
Official information
In the USA
Same active substance: Qalsody
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Qalsody used for?
Qalsody is indicated for the treatment of adults with amyotrophic lateral sclerosis (ALS), associated with a mutation in the superoxide dismutase 1 (SOD1) gene.
What is the active substance in Qalsody?
Qalsody contains tofersen.
Who makes Qalsody?
The EU marketing authorisation holder is Biogen Netherlands B.V..
Is Qalsody an orphan medicine?
Yes. Qalsody is designated an orphan medicine in the EU, for a rare disease (Amyotrophic Lateral Sclerosis).
Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.
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