Seven new medicines recommended for approval

EMA’s human medicines committee (CHMP) recommended seven medicines for approval at its September 2019 meeting.

The Committee recommended granting a marketing authorisation for Xospata* (gilteritinib) for the treatment of 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.

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

The CHMP recommended granting a marketing authorisation for Rhokiinsa (netarsudil) for the treatment of patients with glaucoma or ocular hypertension.

Senstend (lidocaine / prilocaine), which was evaluated in an informed consent application, received a positive opinion for the treatment of premature ejaculation in adult men. An informed consent application makes use of data from the dossier of a previously authorised medicine, with the marketing authorisation holder of that medicine giving consent for the use of their data in the application.

The CHMP recommended granting marketing authorisations for three generic medicinesArsenic 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.

Eight recommendations on extensions of therapeutic indication

The Committee recommended extensions of indication for Bavencio, Benlysta, Docetaxel Zentiva, Dupixent, Lucentis, Remisima, Taxotere and Trulicity.

Posted on the EMA website on 20 September 2019