CHMP Recommends Seven Medicines for Approval

The EMA’s Committee for Medicinal Products for Human Use recommended seven medicines for approval at its September meeting, including three new drugs, three generics and one orphan drug.

The committee recommended marketing approval for Astellas’ orphan drug Xospata (gilteritinib) for adults who have relapsed or refractory acute myeloid leukemia with a FLT3 mutation.

Aerie Pharmaceutical’s Rhokiinsa (netarsudil) eye drops also received the committee’s nod for treatment of glaucoma and ocular hypertension.

Generic leukemia infusions arsenic trioxide by Accord healthcare, and Orphelia Pharma’s Ivozall (clofarabine) received marketing approval recommendations. Fresenius Kabi Deutschland’s generic bortezomib injection also received a recommendation to treat multiple myeloma and mantle cell lymphoma.

The committee issued positive opinions for AstraZeneca’s type 2 diabetes tablet Qtrilmet (metformin hydrochloride, saxagliptin, dapagliflozin) and Plethora Pharma’s premature ejaculation spray Senstend (lidocaine, prilocaine).