Hepcludex - opinion on variation to marketing authorisation

Opinion

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

bulevirtide

Opinion

On 17 October 2024, 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 Hepcludex. The marketing authorisation holder for this medicinal product is Gilead Sciences Ireland UC.

The CHMP adopted an extension to the existing indication to include children aged 3 years and older weighing at least 10 kg. For information, the full indication will be as follows:¹

Hepcludex is indicated for the treatment of chronic hepatitis delta virus (HDV) infection in plasma (or serum) HDV-RNA positive adult and paediatric patients 3 years of age and older weighing at least 10 kg with compensated liver disease.

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 made 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 Hepcludex (II-31)

AdoptedReference Number: EMA/CHMP/447783/2024

Key facts

• Name of medicine:
  Hepcludex
• EMA product number:
  EMEA/H/C/004854
• Active substance:
  bulevirtide acetate
• International non-proprietary name (INN) or common name:
  bulevirtide
• Therapeutic area (MeSH):
  Hepatitis D, Chronic
• Anatomical therapeutical chemical (ATC) code:
  J05A
• Additional monitoring:

  This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

• 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:
  Gilead Sciences Ireland UC
• Date of opinion:
  17/10/2024
• Status:
  Positive