sodium phenylbutyrate / Ursodoxicoltaurine

Table of contents


Update as of 5 July 2023:
The applicant for Albrioza has requested a re-examination of EMA’s June 2023 opinion. Upon receipt of the grounds of the request, the Agency will re-examine its opinion and issue a final recommendation.

The European Medicines Agency has recommended the refusal of the marketing authorisation for Albrioza, a medicine intended for the treatment of amyotrophic lateral sclerosis (ALS).

The Agency issued its opinion on 22 June 2023. The company that applied for authorisation, Amylyx Pharmaceuticals EMEA B.V., may ask for re-examination of the opinion within 15 days of receiving the opinion.

Key facts

Agency product number
International non-proprietary name (INN) or common name
  • sodium phenylbutyrate
  • Ursodoxicoltaurine
Active substance
  • Sodium phenylbutyrate
  • Ursodoxicoltaurine
Therapeutic area
Amyotrophic Lateral Sclerosis

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Date opinion adopted
Company name
Amylyx Pharmaceuticals EMEA B.V.
Application type
Initial authorisation

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