Celgene International Sàrl, a subsidiary of Celgene Corporation, announced that that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for an expanded indication of VIDAZA® (azacitidine for injection). VIDAZA is approved for the treatment of acute myeloid leukaemia (AML) in adult patients aged 65 years or older who are not eligible for haematopoietic stem cell transplantation (HSCT). The expanded indication now covers patients who have >30% myeloblasts, according to the WHO classification. Whereas, previously, the indication covered AML patients with <30% blasts.
Similarly, the EMA’s CHMP has adopted a positive opinion of the Marketing Authorization Application of Exelixis, Inc.‘s cobimetinib. Cobimetinib is a selective MEK inhibitor, used in combination with vemurafenib, for the treatment of BRAF V600 mutation-positive unresectable or metastatic melanoma. The CHMP’s positive opinion is to be reviewed by the European Commission, which has the authority to approve medicines for the European Union. The European Commission is expected to release its final decision regarding the approval of the combination of cobimetinib and vemurafenib by the end of 2015.
The EMA’s CHMP also bestowed a positive recommendation for the marketing authorization of ELOCTA™ (rFVIIIFc), which was announced by Biogen and Swedish Orphan Biovitrum AB (publ) (Sobi). ELOCTA is a recombinant factor VIII Fc fusion protein product for the treatment of hemophilia A. If approved, it would be the first hemophilia A treatment with prolonged circulation available in the European Union (EU).