CHMP Recommends Otsuka Pharmaceutical Co., Ltd.'s Deltyba (Delamanid) For EU Approval For Treatment Of Multidrug-Resistant Tuberculosis (MDR-TB) In Combination With Optimized Background Regimen (OBR)
11/25/2013 8:09:36 AM
TOKYO--(BUSINESS WIRE)--Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended approval of DeltybaTM (delamanid) in combination with a WHO recommended optimized background regimen (OBR)1 for the treatment of pulmonary multidrug-resistant tuberculosis (MDR-TB) . The CHMP opinion will help form the basis for a European Commission decision expected early next year.
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