The EMA’s human medicines committee (CHMP) has recommended seven medicines for approval at its September 2019 meeting.
The first of the round-up is Astellas’ Xospata (gilteritinib), for which the committee recommended granting a marketing authorisation for adult patients who have relapsed or refractory acute myeloid leukaemia (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 EMA’s accelerated assessment procedure, reserved for medicines of major public health interest.
AstraZeneca’s Qtrilmet (metformin hydrochloride / saxagliptin / dapagliflozin) also received a positive opinion from the CHMP for the treatment of type II diabetes mellitus.
Further, the committee recommended granting a marketing authorisation for Rhokiinsa (netarsudil), an Aerie drug for the treatment of patients with glaucoma or ocular hypertension.
Plethora Pharma’s Senstend (lidocaine / prilocaine) was also among the recommendations, receiving a positive opinion for the treatment of premature ejaculation in adult men after being evaluated in an informed consent application.
It also recommended granting marketing authorisations for three generic medicines: Arsenic trioxide Accord (arsenic trioxide), for the treatment of acute promyelocytic leukaemia; Bortezomib Fresenius Kabi (bortezomib), for the treatment of multiple myeloma and mantle cell lymphoma; and Ivozall (clofarabine), for the treatment of acute lymphoblastic leukaemia in paediatric patients.
The full agenda of the September 2019 meeting is published on EMA’s website.
