
EU committee likely to recommend against approving Amylyx ALS drug, company says
Amylyx Pharmaceuticals’ ALS drug is seemingly headed for a rockier path in the EU than it faced in the US and Canada.
The biotech announced Tuesday morning that the bloc’s drug review committee, known as CHMP, is expected to issue a “negative opinion” and recommend against approving the drug next month. If that negative opinion comes to pass, Amylyx expects to appeal in a “formal re-examination,” per a company press release.
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.