CHMP recommends approval of Deltyba for Tuberculosis-Otsuka
The CHMP recommended granting a conditional marketing authorisation for Deltyba (delamanid) from Otsuka, for the treatment of adult patients with pulmonary infections due to multidrug-resistant Tuberculosis when an effective treatment regimen cannot otherwise be devised for reasons of resistance or tolerability.This is the outcome of a re-examination of the CHMP�s previous recommendation to refuse granting of a marketing authorisation for Deltyba adopted on 25 July 2013.
Multidrug-resistant Tuberculosis is defined as Tuberculosis caused by Mycobacterium tuberculosis that is resistant to at least isoniazid and rifampicin, which are two anti-tuberculosis medicines used in standard treatment. Approximately 450,000 cases of multidrug-resistant tuberculosis occur globally every year, which corresponds to approximately 5% of the world�s annual burden of Tuberculosis. In the European Union, Tuberculosis is an orphan indication.
Learning Zones
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