Copiktra

Withdrawn

This medicine's authorisation has been withdrawn

duvelisib

Overview

On 16 February 2026, the European Commission withdrew the marketing authorisation for Copiktra (duvelisib) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Secura Bio Limited, which notified the European Commission of its decision not to market the product in the EU for commercial reasons.

Copiktra was granted marketing authorisation in the EU on 19 May 2021 for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukaemia (CLL) or refractory follicular lymphoma (FL). The marketing authorisation was initially valid for a 5-year period. The product has never been marketed in the EU.

Therapeutic alternatives are available throughout the EU. Patients taking Copiktra or participating in a clinical trial are advised to consult their doctor.

Copiktra : EPAR – Medicine overview

Reference Number: EMA/242496/2021

Copiktra : EPAR - Risk-management-plan summary

Product information

Copiktra : EPAR - Product information

Copiktra : EPAR - All authorised presentations

Product details

• Name of medicine:
  Copiktra
• Active substance:
  duvelisib
• International non-proprietary name (INN) or common name:
  duvelisib
• Therapeutic area (MeSH):
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Lymphoma, Follicular
• Anatomical therapeutic chemical (ATC) code:
  L01EM04

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Copiktra monotherapy is indicated for the treatment of adult patients with: 

• Relapsed or refractory chronic lymphocytic leukaemia (CLL) after at least two prior therapies. 
• Follicular lymphoma (FL) that is refractory to at least two prior  systemic therapies.

Authorisation details

• EMA product number:
  EMEA/H/C/005381
• Marketing authorisation holder:
  Secura Bio Limited

  Secura Bio Limited; 32 Molesworth Street; Dublin 2; Ireland

• Opinion adopted:
  25/03/2021
• Marketing authorisation issued:
  19/05/2021
• Withdrawal of marketing authorisation:
  16/02/2026
• Revision:
  3

Assessment history

Changes since initial authorisation of medicine

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

Initial marketing authorisation documents

Copiktra : EPAR - Public assessment report

Adopted Reference Number: EMA/CHMP/236249/2021

Copiktra : Orphan designation withdrawal assessment report (initial authorisation)

Adopted Reference Number: EMADOC-1700519818-645386

CHMP summary of positive opinion for Copiktra

Adopted Reference Number: EMA/CHMP/84697/2021