LONDON — A European regulatory panel has taken a negative view of whether an ALS treatment from Amylyx Pharmaceuticals should win approval, the company said Tuesday, threatening the drug’s chances of entering the European market.
In a statement, Amylyx said it had learned that a European Medicines Agency’s committee “is trending toward a negative opinion” on the drug, AMX0035, after its May meeting last week.
The committee is expected to issue its formal opinion next month, a recommendation that then goes to the European Commission, which makes the final authorization decision. The commission typically follows the committee’s guidance.
This article is exclusive to STAT+ subscribers
Unlock this article — plus daily coverage and analysis of the biotech sector — by subscribing to STAT+.
Already have an account? Log in
Already have an account? Log in
To submit a correction request, please visit our Contact Us page.
STAT encourages you to share your voice. We welcome your commentary, criticism, and expertise on our subscriber-only platform, STAT+ Connect