By Adriano Marchese
Amylyx Pharmaceuticals said Friday that it received an initial negative opinion from an EU regulator on the marketing authorization application for its treatment of amyotrophic lateral sclerosis, also known as ALS, in the EU.
The Cambridge, Mass.-based biopharmaceutical company said the Committee for Medicinal Products for Human Use of the European Medicines Agency confirmed its initial negative opinion on the marketing authorization application for its drug, AMX0035, under the trade name Albrioza.
Amylyx said the decision followed the conclusion of the CHMP’s formal re-examination procedure of an initial negative opinion adopted earlier in June.
Albrioza was approved with conditions by Health Canada in June 2022 and was granted a full approval by the U.S. Food and Drug Administration under the trade name Relyvrio in September 2022.
The company said it continues to push towards the completion of the Phoenix phase 3 clinical trial, which began before it submitted the MAA. Amylyx said that it expects the trial will shed more light on the efficacy and safety profile of its drug. If the trial is supportive, Amylyx said it plans to seek approval in the EU as quickly as possible.
The results are anticipated in mid-2024, it said.
Write to Adriano Marchese at [email protected]
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