Wall Street Journal (11.22.2013)
An article in the Wall Street Journal reported that a European Union panel recommended regulatory approval of a new TB drug. The European Medicines Agency’s Committee for Medicinal Products for Human Use recently announced its conditional approval of the drug delamanid, manufactured by Otsuka Pharmaceutical Company of Japan. The committee withheld its approval in July and requested further study, as it did not consider the two-month study with 481 drug-resistant patients sufficient to determine the drug’s efficacy in the usual six-month treatment course.
The committee has reversed its decision, allowing conditional approval of delamanid to treat drug- resistant pulmonary TB, but kept its requirement that the pharmaceutical company conduct additional studies on long-term benefits and safety. After reviewing the data and consulting with infectious disease experts, the committee believed that the drug would be effective throughout six months similar to its results in the two-month study.
If delamanid is approved eventually, it would be the second major new TB treatment developed since the 1970s. The first new drug was Johnson & Johnson’s bedaquiline, which the US Food and Drug Administration approved in 2012. Bedaquiline is used with other drugs to treat multidrug-resistant TB (MDR TB), which infects approximately 450,000 people a year and kills 170,000. Delamanid also would be used in combination with other drugs to treat MDR TB. European approval of delamanid would be very important, as Eastern Europe has some of the highest rates of MDR TB in the world.