EMA Recommends Approval of 11 Drugs
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19 September 2016
BioPharm International
The agency recommended approval of 11 drugs, including three cancer drugs, in September.
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended approval of 11 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.
- Marketing authorization of SomaKit-TOC (edotreotide) an orphan drug for the diagnosis of gastro-entero-pancreatic neuroendrocrine tumors.
- 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.
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