Bylvay - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation.

odevixibat

Opinion

On 20 July 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Bylvay. The marketing authorisation holder for this medicinal product is Albireo AB.

The CHMP adopted a new indication for the treatment of Alagille syndrome.  For information, the full indications for Bylvay will therefore be as follows¹:

Progressive familial intrahepatic cholestasis (PFIC)

Bylvay is indicated for the treatment of progressive familial intrahepatic cholestasis (PFIC) in patients aged 6 months or older (see sections 4.4 and 5.1).

Alagille syndrome (ALGS)

Bylvay is indicated for the treatment of cholestatic pruritus in Alagille syndrome (ALGS) in patients aged 6 months or older (see sections 4.4 and 5.1).

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

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¹New text in bold

CHMP post-authorisation summary of positive opinion for Bylvay (II-11 )

Adopted

Key facts

• Name of medicine:
  Bylvay
• EMA product number:
  EMEA/H/C/004691
• Active substance:
  Odevixibat
• International non-proprietary name (INN) or common name:
  odevixibat
• Therapeutic area (MeSH):
  Cholestasis, Intrahepatic
• Anatomical therapeutical chemical (ATC) code:
  A05AX
• Accelerated assessment:

  This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment.

• Exceptional circumstances:

  This medicine was authorised under exceptional circumstances, because the applicant was unable to provide comprehensive data on the efficacy and safety of the medicine under normal conditions of use. This can happen because the condition to be treated is rare or because collection of full information is not possible or is unethical. For more information, see Pre-authorisation guidance.

• Orphan:

  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.

• PRIME: priority medicine:

  This medicine was granted entry to the EMA Priority Medicines (PRIME) scheme during its development. PRIME is a scheme launched by EMA to enhance support for the development of medicines that target an unmet medical need. This voluntary scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimise development plans and speed up evaluation so these medicines can reach patients earlier. For more information, see PRIME: priority medicines.

• Marketing authorisation holder:
  Ipsen Pharma
• Date of opinion:
  20/07/2023
• Status:
  Positive