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Home » Still a no for Amylyx’s ALS drug Albrioza as European regulator upholds negative vote
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Still a no for Amylyx’s ALS drug Albrioza as European regulator upholds negative vote

Oct. 16, 2023
By Caroline Richards
The EMA is standing firm on its refusal to recommend approval of the amyotrophic lateral sclerosis (ALS) treatment Albrioza in Europe after re-examining Amylyx Pharmaceuticals Inc.’s marketing authorization application and remaining unconvinced that the main study demonstrated the drug effectively slows disease progression.
BioWorld Regulatory Musculoskeletal Neurology/psychiatric Europe CHMP EMA

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