Health Canada approves Amylyx’s ALS therapy as FDA mulls more data 

Although Amylyx has to wait longer than expected for FDA to complete its review of amyotrophic lateral sclerosis therapy Albrioza, the biotech has secured its first approval worldwide — both the company’s first and the drug’s — from Health Canada. ICER said it intends to release a draft evaluation of the therapy Tuesday.

The Canadian approval came via the agency’s equivalent to FDA’s accelerated approval pathway, called the notice of compliance with conditions (NOC/c) policy. That means the approval is subject to conditions, including submission of future data from the ongoing Phase III PHOENIX trial to confirm clinical benefit. ...