CHMP recommends rejecting Amylyx ALS drug, pitting EMA against FDA and Health Canada
The European Medicines Agency recommended that Amylyx Pharmaceuticals’ ALS drug be rejected within the EU.
The drug, known as Relyvrio in the US and Albrioza in Canada and the EU, did not “convincingly” show that it could slow the worsening of ALS in a clinical trial, the EMA’s Committee for Medicinal Products for Human Use (CHMP) said Friday. As a result, regulators could not say for certain that the benefits outweigh the risks.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.