Beqvez (previously Durveqtix)

Withdrawn

This medicine's authorisation has been withdrawn

fidanacogene elaparvovec

Overview

On 15 May 2025, the European Commission withdrew the marketing authorisation for Beqvez (fidanacogene elaparvovec) in the European Union (EU). The withdrawal was requested by the marketing authorisation holder, Pfizer Europe MA EEIG, due to commercial reasons.

Beqvez was granted conditional marketing authorisation in the EU on 24 July 2024 for the treatment of severe and moderately severe haemophilia B. The product had not been marketed in the EU.

Durveqtix : EPAR - Medicine overview

Reference Number: EMA/331501/2024

Durveqtix : EPAR - Risk management plan

Product information

Beqvez : EPAR - Product information

Beqvez : EPAR - All authorised presentations

Product details

• Name of medicine:
  Beqvez (previously Durveqtix)
• Active substance:
  fidanacogene elaparvovec
• International non-proprietary name (INN) or common name:
  fidanacogene elaparvovec
• Therapeutic area (MeSH):
  Hemophilia B

Pharmacotherapeutic group

Antihemorrhagics

Authorisation details

• EMA product number:
  EMEA/H/C/004774
• Advanced therapy:

  This medicine is classified as an advanced therapy medicinal product (ATMP): a medicine for human use that is based on genes, tissues or cells. It offers groundbreaking new opportunities for the treatment of disease and injury. For more information, see Advanced therapy medicinal products: Overview.

• Conditional approval:

  This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.

• 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:
  Pfizer Europe MA EEIG

  Boulevard de la Plaine 17; 1050 Bruxelles; Belgium

• Opinion adopted:
  30/05/2024
• Marketing authorisation issued:
  24/07/2024
• Withdrawal of marketing authorisation:
  15/05/2025
• Revision:
  3

Assessment history

Changes since initial authorisation of medicine

Beqvez : EPAR - Procedural steps taken and scientific information after authorisation

Beqvez : EPAR - Procedural steps taken and scientific information after authorisation (archive)

Initial marketing authorisation documents

Durveqtix : EPAR - Public assessment report

AdoptedReference Number: EMA/323453/2024

CHMP summary of positive opinion for Durveqtix

Reference Number: EMA/CHMP/232716/2024