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.
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