EMA Recommends Approval of 10 Drugs

September 16, 2016

The agency recommended approval of 11 drugs, including three cancer drugs, in September.

Updated 9/21/16

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended approval of 10 drugs during their Sept. 12–15, 2016 meeting. The approved drugs treat a range of conditions including different forms of cancer, type 2 diabetes, secondary hyperparathyroidism, heart failure, and HIV.

CHMP recommended the following:

  • Conditional marketing authorization was given to Lartruvo, for the treatment of adults with advanced soft tissue sarcoma.

  • Marketing authorization for Ibrance, for the treatment of locally advanced or metastatic breast cancer.

  • Conditional marketing authorization for Ninlaro (ixazomib) for the treatment of multiple myeloma.

  • Approval of Glyxambi (empagliflozin/linagliptin) for the treatment of type 2 diabetes.

  • Approval of Parsabiv (etelcalcetide) for the treatment of secondary hyperparathyroidism.

  • Positive opinion for Chenodeoxycholic acid sigma-tau (chenodeoxycholic acid) for the treatment of cerebrotendinous xanthomatosis. 

CHMP also recommended the approval of four generic drugs: Ivabradine JensenR (ivabradine) and Ivabradine Zentiva (ivabradine) to treat angina pectoris and heart failure, Emtricitabine/ Tenofovir disoproxil Zentiva (emtricitabine/tenofovir disoproxil) to treat HIV infection, and Granpidam (sildenafil) for the treatment of patients with pulmonary arterial hypertension.

Source: EMA