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Otsuka wins approval for TB drug Deltyba

Second drug approved by EC in 2014 for multidrug resistant tuberculosis

Otsuka Pharma logoOtsuka Pharmaceutical's Deltyba has become the second medicine approved this year in the EU to treat multidrug resistant (MDR) forms of tuberculosis (TB).

This week the European Commission granted the Japanese firm authorisation to market Deltyba (delamanid) almost two months after backing Johnson & Johnson's Sirturo (bedaquiline) in a similar indication.

The two drugs are a significant step forward for the treatment of TB, which is increasingly growing  resistant to current antibiotic treatments. According to the World Health Organization (WHO), there are about 170,000 deaths globally each year due to MDR-TB.

Deltyba's approval covers its use as part of an appropriate combination regimen for pulmonary MDR-TB in adults, as per its recommendation from the European Medicines Agency (EMA) in November 2013.

Otsuka had initially looked likely to beat J&J to marketing authorisation for a new MDR-TB drug in Europe, but the company experienced some regulatory issues for Deltyba that slowed down the approval process.

The EMA's Committee for Medicinal Products for Human Use (CHMP) declined to recommend the drug back in July 2013, claiming the two-month duration of treatment assessed in clinical trials was “too short to establish the effectiveness of delamanid”.

Otsuka challenged this recommendation, and the CHMP later recommended Deltyba after a re-examination of the information supplied by Otsuka.

This data included results from clinical trials across nine countries which showed that almost half of patients treated with Deltyba were no longer infectious after two months of treatment, compared to just 29.6 per cent of patients treated with placebo. Both trials arms also received other therapies.

Akihiko Otsuka, chairman of Otsuka, said that MDR-TB remained a “serious problem” for the world.

“When rifampicin was developed half a century ago, it seemed that the world's TB problem was over,” he said. “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.”

Lucane Pharma's treatment Para-aminosalicylic acid Lucane was also recommended for MDR-TB in Europe in November last year, although it is still to receive full marketing authorisation.

1st May 2014

From: Sales, Healthcare



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