EMA Refused: Albrioza (sodium phenylbutyrate;ursodoxicoltaurine) — Amylyx Pharmaceuticals EMEA B.V.

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Summary

The EMA refused approval for Albrioza (sodium phenylbutyrate; ursodoxicoltaurine) for amyotrophic lateral sclerosis.

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Diseases / indications

• Amyotrophic Lateral Sclerosis

Drugs mentioned

• Albrioza (sodium phenylbutyrate; ursodoxicoltaurine)

Snippet

Status: Refused. Therapeutic area: Amyotrophic Lateral Sclerosis. MAH: Amylyx Pharmaceuticals EMEA B.V.. Decision date: 12/10/2023. Orphan medicine