Johnson ‘N’ Johnson has won approval from The Food and Drug Administration for a tuberculosis drug that is the first new medicine to fight the deadly infection in more than four decades.
According to ABC News, the agency approved the company’s pill, Sirturo, for use with older drugs to fight a hard-to-treat strain of tuberculosis that has not responded to other medications.
But the agency cautioned that the drug carries risks of potentially deadly heart problems and should be prescribed carefully by
doctors, the report added.
Roughly one-third of the world””s population is estimated to be infected with the bacteria causing tuberculosis. The disease is
rare in the U.S., but kills about 1.4 million people a year worldwide. About 60 percent of all cases are concentrated in China,
India, Russia and Eastern Europe.
Sirturo, known chemically 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.
The standard drugs used to fight the disease were developed in the 1950s and 1960s.
Since the antibiotics used to treat tuberculosis have been around for at least 40 years, the bacterium has become more and
more resistant to what we have, said Chrispin Kambili, global medical affairs leader for Johnson ‘N’ Johnson Janssen division.
The drug carries a boxed warning indicating that it can interfere with the heart””s electrical activity, potentially leading to fatal
heart rhythms.
Sirturo can provide much-needed treatment for patients who don””t have other therapeutic options available, said Edward Cox,
director of the FDA””s antibacterial drugs office.
However, he noted that because the drug also carries some significant risks, doctors should make sure they use it appropriately
and only in patients who don””t have other treatment options.
The FDA said it approved the drug based on two mid-stage studies enrolling 440 patients taking Sirturo. Both studies were
designed to measure how long it takes patients to be free of tuberculosis.
Results from the first trial showed most patients taking Sirturo plus older drugs were cured after 83 days, compared with 125
days for those taking a placebo plus older drugs. The second study showed most Sirturo patients were cured after 57 days.
—-ANI