The U.S. Food and Drug Administration on 31 December 2012 approved a Johnson & Johnson tuberculosis drug that is counted to be first new medicine to fight the deadly infection in more than four decades.
The agency approved J&J’s pill, named Sirturo, for use with older drugs to fight a hard-to-treat strain of tuberculosis that has not responded to other medications.
Sirturo, which chemically known as bedaquiline, is the first medicine specifically designed for treating multidrug-resistant tuberculosis. That’s a form of the disease that cannot be treated with at least two of the four primary antibiotics used for tuberculosis.
Sirturo provides much-needed treatment for patients who don’t have other therapeutic options available.
However, it was also mentioned by the agency that the drug carries risks of potentially deadly heart problems and should be prescribed carefully by doctors. The drug carries a boxed warning indicating that it can interfere with the heart’s electrical activity, potentially leading to fatal heart rhythms.
It is estimated that roughly one-third of the world’s population is infected with the bacteria causing tuberculosis. The disease is rare in the U.S., but kills about 1.4 million people a year worldwide. Of those, about 150,000 succumb to the increasingly common drug-resistant forms of the disease. About 60 per cent of all cases are concentrated in China, India, Russia and Eastern Europe.
The standard drugs used to fight the disease were developed in the 1950s and 1960s.
It was seen during company testing that Nine patients taking Sirturo died compared with two patients taking a placebo. Five of the deaths in the Sirturo group seemed to be related to tuberculosis, but no explanation was apparent for the remaining four.
Regardless of the deaths, the FDA approved the drug under its accelerated approval program, which allows the agency to clear innovative drugs based on promising preliminary results.