CHMP recommends Dacogen (Janssen/Eisai) for Acute Myeloid Leukemia

On 19 July 2012, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Dacogen, 50 mg, powder for concentrate for solution for infusion, from Eisai/Janssen and intended for the treatment of Acute Myeloid Leukaemia. Dacogen was designated as an orphan medicinal product on 8 June 2006. The applicant for this medicinal product is Janssen-Cilag International NV which will market the drug outside North America. The FDA has not yet accepted the drug.