Four medicines recommended for approval by EMA/CHMP

22 December 2013

Following regular monthly meeting of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP; December 16-19), there were positive opinions for four investigational drugs issued on Friday.

Firstly, the CHMP has recommended granting a conditional marketing authorization for US health care giant Johnsons & Johnson (NYSE; JNJ subsidiary Janssen Cilag’s Sirturo (bedaquiline) for use as part of a combination therapy for pulmonary multidrug-resistant tuberculosis in adults when an effective treatment regime cannot otherwise be composed for reasons of resistance or tolerability. Sirturo has an orphan designation

Additional studies are required post authorization to further define the optimal use of this agent, both with regards the number and types of agents that are needed in combination, and the optimal treatment duration.

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