On 12 December 2019, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Azacitidine Accord, intended for the treatment of myelodysplastic syndromes (MDS), chronic myelomonocytic leukaemia (CMML) and acute myeloid leukaemia (AML).
The applicant for this medicinal product is Accord Healthcare S.L.U.
Azacitidine Accord will be available as a 25 mg/ml powder for suspension for injection. The active substance of Azacitidine Accord is azacitidine, a pyrimidine analogue (ATC code: L01BC07) which exerts its antineoplastic effects by multiple mechanisms, including cytotoxicity on cells in the bone marrow and hypomethylation of DNA.
Azacitidine Accord is a generic of Vidaza, which has been authorised in the EU since 17 December 2008. Studies have demonstrated the satisfactory quality of Azacitidine Accord. Since Azacitidine Accord is administered intravenously and is 100% bioavailable, a bioequivalence study versus the reference product Vidaza was not required.
The full indication is:
Azacitidine Accord is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation with:
- Intermediate 2 and high-risk MDS according to the International Prognostic Scoring System,
- CMML with 10-29% marrow blasts without myeloproliferative disorder,
- AML with 20-30% blasts and multi-lineage dysplasia, according to World Health Organisation (WHO) classification,
- AML with >30% marrow blasts according to the WHO classification.
It is proposed that Azacitidine Accord be prescribed by physicians experienced in the use of chemotherapeutic agents.
Detailed recommendations for the use of this product will be described in the summary of product characteristics, which will be published in the European public assessment report and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.
Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion.