U.S. FDA approves first new
tuberculosis ( KNOWN AS T.B.)drug in 40 years
WASHINGTON -- The Food and Drug Administration on Monday approved a Johnson &
Johnson tuberculosis drug that is the first new medicine to fight the deadly
infection in more than four decades.
The agency approved J&J's pill, Sirturo, for use with older drugs to fight a
hard-to-treat strain of tuberculosis that has not responded to other
medications. However, the agency cautioned that the drug carries risks of
potentially deadly heart problems and should be prescribed carefully by doctors.
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. Of those, about 150,000 succumb to the
increasingly common drug-resistant forms of the disease. 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.
"The antibiotics used to treat it have been around for at least 40 years and so
the bacterium has become more and more resistant to what we have," said Chrispin
Kambili, global medical affairs leader for J&J's 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 provides much-needed treatment for patients who have don't have other
therapeutic options available," said Edward Cox, director of the FDA's
antibacterial drugs office. "However, 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."
Nine patients taking Sirturo died in company testing 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.
Despite 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.
Last week, the consumer advocacy group Public Citizen criticized that approach,
noting the drug's outstanding safety issues.
"The fact that bedaquiline is part of a new class of drug means that an
increased level of scrutiny should be required for its approval," the group
states. "But the FDA had not yet answered concerns related to unexplained
increases in toxicity and death in patients getting the drug."
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.