Alofisel

Withdrawn

This medicine's authorisation has been withdrawn

darvadstrocel

Overview

On 13 December 2024, the European Commission withdrew the marketing authorisation for Alofisel (darvadstrocel) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Takeda Pharma A/S, which notified the European Commission of its decision to permanently stop the marketing of the product in the EU.

Alofisel was granted marketing authorisation in the EU on 23 March 2018 for the treatment of complex perianal fistulas. The European Public Assessment Report (EPAR) for Alofisel is updated to indicate that the marketing authorisation is no longer valid.

Alofisel : EPAR - Summary for the public

Reference Number: EMA/1380/2018

Alofisel : EPAR - Risk-management-plan summary

Product information

Alofisel : EPAR - Product information

Alofisel : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Alofisel
• Active substance:
  darvadstrocel
• International non-proprietary name (INN) or common name:
  darvadstrocel
• Therapeutic area (MeSH):
  Rectal Fistula
• Anatomical therapeutic chemical (ATC) code:
  L04

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Alofisel is indicated for the treatment of complex perianal fistulas in adult patients with non-active/mildly active luminal Crohn’s disease, when fistulas have shown an inadequate response to at least one conventional or biologic therapy. Alofisel should be used after conditioning of fistula.

Authorisation details

• EMA product number:
  EMEA/H/C/004258
• 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.

• 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.

• Marketing authorisation holder:
  Takeda Pharma A/S

  Delta Park 45; 2665 Vallensbaek Strand; Denmark

• Opinion adopted:
  14/12/2017
• Marketing authorisation issued:
  23/03/2018
• Withdrawal of marketing authorisation:
  13/12/2024
• Revision:
  12

Assessment history

Changes since initial authorisation of medicine

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

Alofisel-H-C-004258-II-0051-G : EPAR - Assessment report - Variation

Reference Number: EMA/598555/2024

Initial marketing authorisation documents

Alofisel : Orphan maintenance assessment report (initial authorisation)

Reference Number: EMA/92608/2018

Alofisel : EPAR - Public assessment report

AdoptedReference Number: EMA/CHMP/64055/2018

CHMP summary of positive opinion for Alofisel

AdoptedReference Number: EMA/CHMP/815767/2017