EU/3/18/2103

About

On 14 December 2018, orphan designation (EU/3/18/2103) was granted by the European Commission to Albireo AB, Sweden, for (2S)-2-{[(2R)-2-[({[3,3-dibutyl-7-(methylthio)-1,1-dioxido-5-phenyl-2,3,4,5-tetrahydro-1,2,5-benzothiadiazepin-8-yl]oxy}acetyl)amino]-2-(4-hydroxyphenyl)acetyl]amino}butanoic acid (also known as A4250) for the treatment of biliary atresia.

Key facts

Active substance
(2S)-2-{[(2R)-2-[({[3,3-dibutyl-7-(methylthio)-1,1-dioxido-5-phenyl-2,3,4,5-tetrahydro- 1,2,5-benzothiadiazepin-8-yl]oxy}acetyl)amino]-2-(4-hydroxyphenyl)acetyl]amino}butanoic acid
Disease / condition
Treatment of biliary atresia
Date of first decision
14/12/2018
Outcome
Positive
EU designation number
EU/3/18/2103

Review of designation

The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.

Sponsor's contact details

Albireo AB
Arvid Wallgrens Backe 20
S-413 46 Gothenburg
Sweden
Tel. +46 31 741 14 80
E-mail: info@albireopharma.com

Patients' organisations

For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

  • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

  • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe;

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