Trial Profile
A Phase 1, Safety, Tolerability, and Distribution Study of a Microdose of Radiolabeled BIIB067 Co-administered With BIIB067 to Healthy Adults
Status:
Completed
Phase of Trial:
Phase I
Latest Information Update: 04 Mar 2024
Price :
$35
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At a glance
- Drugs Tofersen (Primary)
- Indications Amyotrophic lateral sclerosis
- Focus Pharmacokinetics
- Sponsors Biogen
- 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.
- 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 Jan 2023 According to a Biogen media release, the U.S. Food and Drug Administration (FDA) will convene a virtual meeting of the Peripheral and Central Nervous System Drugs Advisory Committee for the New Drug Application (NDA) for tofersen for the treatment of superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS).