The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has approved six new medicines at its May meeting.
The medicines approved for use include:
- Two new combination therapies – sofosbuvir/velpatasvir (Epclusa) and grazoprevir/elbasvir (Zepatier) to treat chronic (long-term) hepatitis C
- Saxagliptin/dapagliflozin (Qtern) for the treatment of type 2 diabetes mellitus
- Bortezomib (Bortezomib Hospira) and Bortezomib Sun for the treatment of multiple myeloma and mantle cell lymphoma
- Pemetrexed (Pemetrexed Fresenius Kabi) for the treatment of unresectable malignant pleural mesothelioma and locally advanced or metastatic non-small cell lung cancer.
Additionally, the CHMP provided a negative opinion on ixazomib (Ninlaro). Ixazomib was expected to be used for treating multiple myeloma in adults who had received at least one prior treatment. CHMP also recommended extensions of indications for Adcetris, Humira, Kyprolis, Revestive, Simponi and Tysabri. The CHMP also agree to re-examine the application for glycopyrronium bromide (Sialanar) following the negative opinion for this medicine adopted at the April meeting.
More information about the outcome of the May 2016 CHMP can be found here.