Trial Profile
A Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB067 Administered to Adult Subjects With Amyotrophic Lateral Sclerosis and Confirmed Superoxide Dismutase 1 Mutation
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 27 Feb 2024
Price :
$35
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At a glance
- Drugs Tofersen (Primary)
- Indications Amyotrophic lateral sclerosis
- Focus Adverse reactions; Pharmacokinetics; Proof of concept; Registrational; Therapeutic Use
- Acronyms VALOR
- Sponsors Biogen
- 23 Feb 2024 According to a Biogen media release, the CHMP's recommendation for QALSODY will now be reviewed by the EC for a decision on a marketing authorization in the European Union, with a decision expected in the second quarter of 2024.
- 23 Feb 2024 According to a Biogen media release, company announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending a marketing authorization under exceptional circumstances for QALSODY (tofersen) for the treatment of adults with amyotrophic lateral sclerosis, associated with a mutation in the superoxide dismutase 1 gene.
- 25 Apr 2023 According to Ionis Pharmaceuticals media release, Biogen has received USFDA approval of QALSODY (tofersen) 100 mg/15mL injection for the treatment of amyotrophic lateral sclerosisin adults who have a mutation in the superoxide dismutase 1 gene. This indication is approved under accelerated approval based on a reduction in plasma neurofilament light chain observed in patients treated with QALSODY; The approval of QALSODY was supported by 12 month integrated results from VALOR and its OLE study.