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These highlights do not include all the information needed to use QALSODY ™ safely and effectively. See full prescribing information for QALSODY. QALSODY (tofersen) injection, for intrathecal use Initial U.S. Approval: 2023
Medication labelWhy this: Advisory · dailymed-prescription
QALSODY is indicated for the treatment of amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the superoxide dismutase 1 (SOD1) gene. This indication is approved under accelerated approval based on reduction in plasma neurofilament light chain (NfL) observed in patients treated with QALSODY [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).
- generic_name
- tofersen
- product_names
- tofersen
- ndc
- 64406-109, 64406-109-01
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en