EMA Highlights: Green light for six new medicines

by Gary Finnegan: Six medicines, including two combination therapies for chronic hepatitis C, have been recommended for approval at the May meeting of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

The Committee’s view is shared with the European Commission which formally grants marketing licenses for new medicines in Europe. It also recommended the extension of indications for Adcetris, Humira, Kyprolis, Revestive, Simponi and Tysabri.


The newly-approved drugs are:

  • Epclusa (sofosbuvir/velpatasvir) and Zepatier (elbasvir/grazoprevir) to treat chronic (long-term) hepatitis C
  • Qtern (saxagliptin/dapagliflozin) for the treatment of type 2 diabetes mellitus
  • Bortezomib Hospira(bortezomib) and Bortezomib Sun (bortezomib) for the treatment of multiple myeloma and mantle cell lymphoma
  • Pemetrexed Fresenius Kabi(pemetrexed) for the treatment of unresectable malignant pleural mesothelioma and locally advanced or metastatic non-small cell lung cancer.