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news.Celgene International has announced that its cancer drug, Vidaza, has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use for the treatment of adult patients with myelodysplastic syndromes, acute myeloid leukemia and chronic myelomonocytic leukemia.
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The positive opinion includes important survival data from the AZA-001 trial in higher-risk myelodysplastic syndromes (MDS) patients. The Committee for Medicinal Products for Human Use (CHMP), which reviews applications for all 27 member states in the EU as well as Norway and Iceland, has recommended approval for Vidaza (azacitidine).
The CHMP’s positive opinion will be forwarded to the European Commission, which generally follows the recommendation of the CHMP and typically issues final marketing approval within two to three months.
The positive opinion from the CHMP was based upon safety and efficacy from clinical studies evaluating azacitidine in MDS-notably the significant improvement in overall survival achieved in the azacitidine survival trial (AZA-001), the largest, international randomized Phase III controlled study ever conducted in higher-risk MDS.
Philippe Holle, president of Celgene Europe, said: “We are optimistic that Vidaza will have broad support based on its value to patients and to the healthcare system. Upon approval we are prepared to initiate next steps for pricing, reimbursement and distribution plans for all EU member states.”