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Approval fast-tracks access while waiting for more data and studies; U.S. still reviewing
Jun 13, 2022
Health Canada has approved an experimental drug for amyotrophic lateral sclerosis, also known as ALS or Lou Gehrig’s disease, as uncertainty persists about the drug’s clinical benefit.
Amylyx Pharmaceuticals said in a press release Monday that Canada is the first country in the world to give the regulatory green light to Albrioza as a treatment for the devastating neurodegenerative disease.
Health Canada granted its approval under a policy that aims to accelerate market access to promising drugs for serious diseases, with conditions including that the Massachusetts-based manufacturer provide more data and studies.
The regulator’s U.S. counterpart, the Food and Drug Administration (FDA), has deemed it safe but continues to review Albrioza after an independent advisory committee narrowly voted earlier this year that the available evidence on the drug’s effectiveness didn’t meet the threshold for approval. The FDA is expected to make its decision on Sept. 29 after pushing the date by three months to allow for more time to review additional analyses from Amylyx’s clinical studies.
Read more: https://www.cbc.ca/news/health/health-canada-als-drug-albrioza-1.6487460