Otsuka wins EU approval for Deltyba in MDR-TB

Japanese drugmaker Otsuka Pharmaceutical (TYO: 4768) says that the European Commission has 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.

This is the first approval for Deltyba, which was designated as an orphan medicine in 2008 meaning that it is a medicine used to treat a rare disease. Clinical trial results from nine 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.

Akihiko Otsuka, chairman of Otsuka, stated: “It is very pleasing to me that a new drug developed by Otsuka Pharmaceutical has become available to patients in Europe with MDR-TB. Currently, MDR-TB is a serious problem there. When rifampicin was developed half a century ago, it seemed that the world’s TB problem was over. But I specifically selected TB as a research theme for our company. I knew that someone had to do this research because TB was still a huge public health issue in Asia.”