Bad News For Amylyx As EMA Upholds Rejection Of ALS Drug Albrioza

The European Medicines Agency stood by its initial decision to recommend against EU approval of Amylyx’s ALS drug Albrioza after a re-examination, but the company remains hopeful that further trial evidence could support a future EU authorization.

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Amylyx Pharmaceuticals this week failed to convince the European Medicines Agency that its amyotrophic lateral sclerosis (ALS) drug Albrioza (sodium phenylbutyrate/ursodoxicoltaurine) should be approved in the EU, despite the drug having already secured conditional approval in Canada in June 2022 and full regulatory approval in September 2022 in the US, where it is marketed as Relyvrio.

The EMA’s human medicines committee, the CHMP, first issued a negative opinion for Albrioza in June – a decision that Amylyx appealed against. A re-examination took place during the CHMP’s latest meeting, which was held on 9-12 October, following which the committee upheld its negative opinion

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