EMA/CHMP recommends 4 new drugs and 3 generics for approval

At its September meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of four novel medicines and three generic medicines.

The Committee recommended granting a marketing authorization for Astellas Pharma’s  (TYO: 4503) Xospata (gilteritinib) for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation. AML is a rare type of cancer of the white blood cells (cells that fight infections). It affects approximately 1 in 10,000 people in the European Union. Xospata was reviewed under the EMA's accelerated assessment procedure, reserved for medicines of major public health interest.

Qtrilmet (metformin hydrochloride/saxagliptin/dapagliflozin), from AstraZeneca (LSE: AZN), received a positive opinion from the CHMP for the treatment of type 2 diabetes mellitus.