Axitinib Accord

Opinion

EMA has issued an opinion on this medicine

axitinib

Overview

On 25 July 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Axitinib Accord, intended for the treatment of adult patients with renal cell carcinoma (RCC).

The applicant for this medicinal product is Accord Healthcare S.L.U.

Axitinib Accord will be available as 1 mg, 3 mg and 5 mg film-coated tablets. The active substance of Axitinib Accord is axitinib, an antineoplastic agent, protein kinase inhibitor (ATC code: L01EK01). Axitinib inhibits vascular endothelial growth factor receptors (VEGFR)-1, VEGFR-2 and VEGFR-3.

Axitinib Accord is a generic of Inlyta, which has been authorised in the EU since 3 September 2012. Studies have demonstrated the satisfactory quality of Axitinib Accord, and its bioequivalence to the reference product Inlyta. A question and answer document on generic medicines can be found in the questions and answers on generic medicines.

The full indication is:

Axitinib Accord is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine.

Treatment with Axitinib Accord should be conducted by a physician experienced in the use of anticancer therapies.

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

CHMP summary of positive opinion for Axitinib Accord

AdoptedReference Number: EMA/284159/2024

Product details

• Name of medicine:
  Axitinib Accord
• Active substance:
  axitinib
• International non-proprietary name (INN) or common name:
  axitinib
• Therapeutic area (MeSH):
  Carcinoma, Renal Cell
• Anatomical therapeutic chemical (ATC) code:
  L01EK01
• EMA product number:
  EMEA/H/C/006206
• Generic:

  This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

• Marketing authorisation applicant:
  Accord Healthcare S.L.U.
• Opinion adopted:
  25/07/2024
• Opinion status:
  Positive