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Amylyx’s Relyvrio/Albrioza Launch Chugs Along As Firm Gives EU Another Go

Executive Summary

The company reported 3,800 ALS patients on drug, a figure that came in slightly below some analyst estimates but which suggested discontinuation rates consistent with the pivotal trial.

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Regulators Still To Get To Grips With Neurodegenerative Outcome Measures

Outcomes measures in the neurodegenerative disease space are not yet well understood by regulators, according to Amylyx, which recently received a negative opinion from the EMA for its amyotrophic lateral sclerosis drug, Albrioza.

Amylyx To Appeal Against EMA Rejection Of ALS Drug Albrioza

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.

Amylyx’s ALS Treatment Relyvrio Beats Expectations Again

The rare disease drug launch continues to outperform expectations, though questions remain about demand and how long patients will remain on the treatment.

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