Tofersen
Other Nervous System Drugs
Sold as Qalsody
- Drug class
- Other Nervous System Drugs
- Availability
- See label
- Routes
- Intrathecal
- Markets covered
- 3
- Products on record
- 3
Overview
Tofersen is an active pharmaceutical ingredient in the Other Nervous System Drugs group (N07XX). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| EU European Union | EMA | 1 | May 11, 2026 |
| GB United Kingdom | MHRA | 1 | May 1, 2026 |
| CA Canada | Health Canada | 1 | September 17, 2025 |
EUEuropean Union· EMA
1 product
Uses
Qalsody is indicated for the treatment of adults with amyotrophic lateral sclerosis (ALS), associated with a mutation in the superoxide dismutase 1 (SOD1) gene.
How to take
GBUnited Kingdom· MHRA
1 product
Uses
Qalsody is indicated for the treatment of adults with amyotrophic lateral sclerosis (ALS), associated with a mutation in the superoxide dismutase 1 (SOD1) gene.
How to take
CACanada· Health Canada
1 product
Uses
QALSODY (tofersen injection) is indicated for: • The treatment of adults with amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 (SOD1) gene. The clinical benefit of QALSODY for the indication remains to be confirmed as this indication is issued market authorization with conditions.
Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). 1 Pediatrics Pediatrics (< 18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.
2 Geriatrics Geriatrics (≥ 65 years of age): Experience with the use of QALSODY in the geriatric population is limited. Evidence from clinical studies suggests that use in the geriatric population is not associated with differences in safety or effectiveness, however a greater sensitivity in some older individuals cannot be ruled out.
Sources & citations
- [1]European Medicines Agency · EMEA/H/C/005493 · revised May 11, 2026
- [2]MHRA (UK) · PL224070034 · revised May 1, 2026
- [3]Health Canada (DPD) · 02555735 · revised September 17, 2025
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.