EMA Recommends Six Medicines for Market Approval

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EMA Recommends Six Medicines for Market Approval

February 27

11:16 2017

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On Feb. 24, 2017, the European Medicines Agency (EMA) announced that its Committee for Medicinal Products for Human Use (CHMP) recommended six medicines for market authorization in the European Union, including an orphan drug for the treatment of chronic hypoparathyroidism. CHMP also recommended extending indications for Darzalex, Mekinist, Tafinlar, and Truvada.

Conditional marketing authorization was given to Natpar (parathyroid hormone), which was given orphan designation and treats chronic hypoparathyroidism that cannot be controlled with calcium and vitamin D. Marketing authorization was given to Lokelma (sodium zirconium cyclosilicate) for the treatment of hyperkalaemia and Varuby (rolapitant) for the prevention of nausea and vomiting.

CHMP granted positive opinion for the informed consent application for Roteas (edoxaban) for the prevention of stroke and systemic embolism in adults with atrial fibrillation, and for the treatment and prevention of deep vein thrombosis and pulmonary embolism. It also granted positive opinions for generics Emtricitabine/Tenofovir disoproxil Krka d.d. (emtricitabine/ tenofovir disoproxil), an HIV treatment, and Pemetrexed Hospira UK Limited (pemetrexed) for the treatment of unresectable malignant pleural mesothelioma and locally advanced or metastatic non-small cell lung cancer.

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