Otsuka Pharmaceutical Co., Ltd. (Otsuka) announced that the European Commission has granted a marketing authorization for Deltyba™ (delamanid) for use as part of an appropriate combination regimen for pulmonary multidrug-resistanttuberculosis (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 Mycobacteriumtuberculosis (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.
y56Deltyba was designated as an orphan medicine in 2008 meaning that it is a medicine used to treat a rare disease. Clinical trial results from 9 countries showed that study subjects treated with Deltyba 100mg twice daily together with an optimized background regimen (OBR) achieved a statistically significant increase in sputum culture conversion (SCC) after two months (45.4% of study subjects) compared to those treated with a placebo (29.6% of study subjects). SCC is a measurement used to determine when a patient is no longer infectious. Deltyba is indicated 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. Clinical trial results demonstrated that adverse events were evenly distributed in the Deltyba and placebo treatment groups with the exception of QT prolongation. Electrocardiogram QT prolongation was reported in 9.9% of patients receiving Deltyba as 100 mg twice daily compared to 3.8% of patients receiving placebo plus OBR. This was not accompanied by any clinical symptoms such as syncope or arrhythmias. The recommended dose for adults is 100 mg twice daily for 24 weeks.