EU committee confirms negative opinion for Amylyx ALS drug, rejecting company appeal

The Eu­ro­pean Med­i­cines Agency re­ject­ed on Fri­day an ap­peal from Amy­lyx Phar­ma­ceu­ti­cals to re­con­sid­er a neg­a­tive re­view opin­ion for its ALS drug Re­lyvrio, fur­ther dim­ming hopes of an ap­proval in the EU.

Reg­u­la­tors on the EMA’s CHMP com­mit­tee said that their “con­cerns were not re­solved” af­ter ini­tial­ly hand­ing down a neg­a­tive opin­ion in June. A fi­nal de­ci­sion will be made by the Eu­ro­pean Com­mis­sion, which typ­i­cal­ly fol­lows the ad­vice of the EMA and CHMP, be­fore the end of the year.

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.