European approved Daphnia anti-infective drug Deltyba

Otsuka Pharmaceutical's anti-infective drug, Deltyba, became the second treatment drug approved for multi-drug resistance (MDR) tuberculosis (TB) in Europe this year. Just about two months before the European Commission approved the listing of the Japanese company Deltyba (delamanid), the committee also approved Johnson's Sirturo (bedaquiline) for similar indications.

These two anti-infective drugs have taken an important step toward the treatment of TB, and TB has become increasingly tolerant of current antibiotic treatment drugs. According to the World Health Organization, approximately 170,000 people die from MDR-TB each year worldwide. The European Medicines Agency CHMP recommended this drug in November 2013.

Otsuka appears to be rushing to market a new MDR-TB treatment drug in Europe prior to Johnson & Johnson, but the company has experienced some setbacks in the application process for the anti-infective drug Deltyba, leading to an extension of its approval process. The EMA Committee on Medicinal Products for Human Use (CHMP) refused to recommend this drug in July 2013, saying that the two-month evaluation of clinical trials was "too short to determine the effectiveness of the drug."

Otsuka Pharmaceutical questioned the idea. After reviewing the information provided by Otsuka Pharmaceutical, CHMP later recommended approval of the drug. The data, which included clinical results from nine countries, showed that approximately half of Deltyba-treated patients were no longer contagious after 2 months of treatment, compared with 29.6% of placebo-treated patients. The two experimental groups also received treatment of other anti-infectives.

Otsuka Pharmaceutical Chairman Akihiko Otsuka stated that MDR-TB is still a medical problem in the world. “When rifampicin, an anti-infective drug, emerged half a century ago, it seems that TB is going to disappear in the world. But I definitely chose TB as a research topic for our company. I know someone must come and do some research because TB is in Asia. It is still a serious public health problem."

Lucane's drug, Lucane, was also recommended for MDR-TB in November last year, but the anti-infective drug still has to wait for a full marketing license.