Trial Profile
An Extension Study to Assess the Long-Term Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB067 Administered to Previously Treated Adults With Amyotrophic Lateral Sclerosis Caused by Superoxide Dismutase 1 Mutation
Status:
Active, no longer recruiting
Phase of Trial:
Phase III
Latest Information Update: 04 Mar 2024
Price :
$35
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At a glance
- Drugs Tofersen (Primary)
- Indications Amyotrophic lateral sclerosis
- Focus Adverse reactions
- 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.
- 18 Oct 2023 According to European Clinical Trials Database record this trial has been Discontinued in Poland according to European Clinical Trials Database record.