Seven new meds recommended for approval, including one orphan, by EMA/CHMP

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended seven medicines for approval, including one orphan medicine, at its January 2018 meeting.

A CHMP positive opinion is one of the final steps before marketing authorization is granted by the European Commission, which is usually forthcoming within two or three months.

The CHMP recommended granting a marketing authorisation for Hemlibra (emicizumab), from Swiss pharma giant Roche (ROG: SIX), a first-in-class medicine to prevent bleeding episodes in patients with hemophilia A who have factor VIII inhibitors. This medicine was reviewed under EMA’s accelerated assessment procedure, reserved for medicines of major public health interest.