7/26/2013 10:13:27 AM
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GENEVA--(BUSINESS WIRE)--Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion for delamanid for the treatment of pulmonary multidrug-resistant tuberculosis (MDR-TB) in combination with an optimised background regimen (OBR) according to WHO guidelines in patients. The CHMP considered that the duration of treatment (two months) in the Phase IIb randomised controlled trial (Trial 204) was too short to establish the effectiveness of delamanid in treating tuberculosis when added to other anti-tuberculosis medicines.
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