Otsuka Pharmaceutical Co has been given the green light to sell its tuberculosis drug Deltyba in Europe.
The European Commission has granted marketing authorisation for Deltyba (delamanid) for use as part of an appropriate combination regimen for pulmonary multidrug-resistant tuberculosis (MDR-TB) in adults when other therapies are resisted or cannot be tolerated. The approval is based on studies which show that subjects treated with Deltyba 100mg twice daily together with an optimised background regimen (OBR) achieved a statistically significant increase in sputum culture conversion after two months (45.4%) compared to those on placebo (29.6% of study subjects). SCC is a measurement used to show when a patient is no longer infectious.
The company quoted Wiel de Lange of the University Medical Center in Groningen, the Netherlands, as saying that with increasing rates of resistance to existing medications "and globally less than half of all MDR-TB cases successfully treated, Deltyba is clearly a welcome new option". While new cases of TB are on the decline across Europe, the number of multidrug-resistant cases has more than doubled from 2008-2012, which has had the effect of nearly tripling the cost per case due to medical care and loss of productivity.
The approval comes some five months after the European Medicines Agency's Committee for Human Medicinal Products recommended approval of Deltyba. That was a reversal of the negative opinion issued in July 2013 after Otsuka requested a re-examination of the file.
Akihiko Otsuka, chairman of the Tokyo-headquartered group stated that 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".
Deltyba is under regulatory review in Japan and Otsuka plans to apply for regulatory approval in high-burden countries.