From their meeting in September, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights.
During the meeting the CHMP announced recommendations for seven medicines for approval. This included two new medicines, one orphan medicine and four generic medicines.
The committee recommended a marketing authorisation for Xospata (gilteritinib) which is a treatment for adults with a relapse of the rare type of cancer acute myeloid leukaemia. This medicine was reviewed under the EMA’s accelerated assessment procedure as it was a major public health interest. They also recommended marketing authorisations for Rhokiinsa (netarsudil) for glaucoma and ocular hypertension, Arsenic trioxide Accord (arsenic trioxide) for acute promyelocytic leukaemia, Bortezomib Fresenius Kabi (bortezomib) for multiple myeloma, and Ivozall (clofarabine) for acute lymphoblastic leukaemia in paediatric patients. Qtrilmet (metformin/saxagliptin/dapagliflozin) for type 2 diabetes mellitus and Senstend (lidocaine/prilocaine) for premature ejaculation also received positive opinions.
The CHMP also recommended extensions of therapeutic indication for eight other medicines; Bavencio, Benlysta, Docetaxel Zentiva, Dupixent, Lucentis, Remisima, Taxotere and Trulicity.
For the meeting summary, and the full list of approvals, opinions and withdrawals, please click here.