EU approves Deltyba for treatment of MDR-TB- Otsuka

Otsuka Pharmaceutical Co., Ltd. announced that the European Commission has, on 29 April 2014, granted a marketing authorization for Deltyba (delamanid) for use as part of an appropriate combination regimen for pulmonary Multidrug-Resistant Tuberculosis (MDR-TB) in adult patients when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability. Deltyba is a bactericidal agent with a novel mode of action that interferes with the metabolism of the Mycobacterium tuberculosis (MTB) cell walls. It also has high activity in vitro against various MTB strains, including those resistant to first-line anti-TB drugs, such as isoniazid and rifampicin. Deltyba was designated as an orphan medicine in 2008 meaning that it is a medicine used to treat a rare disease.

Otsuka has invested in the creation of a Responsible Access Programme (RAP) to help safeguard against the possible emergence of resistance to the medicine. The RAP includes strict distribution control, professional medical education about the proper administration of Deltyba in combination with other MDR-TB drugs, and a comprehensive patient registry to track the safety and efficacy of Deltyba.