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Amylyx To Appeal Against EMA Rejection Of ALS Drug Albrioza

 
• By Neena Brizmohun

Amylyx is standing by the clinical trial data it used to support its EU marketing application for its amyotrophic lateral sclerosis treatment, saying that the same data formed the basis of approvals for Albrioza in the US and Canada.

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The EMA said Amylyx's ALS drug should not be approved in the EU • Source: Shutterstock

Amylyx Pharmaceuticals will be asking the European Medicines Agency to re-examine its decision to recommend against pan-EU marketing approval for Albrioza (sodium phenylbutyrate/ursodoxicoltaurine), the company’s treatment for amyotrophic lateral sclerosis (ALS) that is approved in the US and Canada.

“We are confident in the strength of our CENTAUR trial data, which we believe meets the criteria for conditional approval,” the company said in a statement on

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