Posted by Michael Wonder on 20 Sep 2019
Highlights from the CHMP 16-19 September 2019 meeting
20 September 2019 - Seven new medicines recommended for approval.
The Committee recommended granting a marketing authorisation for Xospata (gilteritinib) for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia with a FLT3 mutation. Xospata was reviewed under EMA's accelerated assessment procedure, reserved for medicines of major public health interest.
Qtrilmet (metformin hydrochloride with saxagliptin and 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.
