The Food and Drug Administration approved a treatment, discovered
by a Johnson & Johnson unit, that can be used when other
tuberculosis drugs fail.
The U.S. Food and Drug Administration has approved a new
treatment for multidrug-resistant tuberculosis that can be used as
an alternative when other drugs fail.
The drug, to be called Sirturo, was discovered by scientists at
Janssen, the pharmaceutical unit of Johnson & Johnson, and is the
first in a new class of drugs that aims to treat the drug-resistant
strain of the disease.
Tuberculosis is a highly infectious disease that is transmitted
through the air and usually affects the lungs, but can also affect
other parts of the body, including the brain and kidneys.
It is considered one of the world's most serious public health
threats. Multidrug-resistant tuberculosis is a growing problem in
the world, especially in poorer countries. About 12 million people
worldwide had tuberculosis in 2011, according to Johnson & Johnson,
and about 630,000 had multidrug-resistant TB.
A study in September in the medical journal The Lancet found that
almost 44 percent of patients with tuberculosis in countries like
Peru, Russia and Thailand showed resistance to at least one second-
line drug, or a medicine used after another drug had already failed.
Treating drug-resistant tuberculosis can take years and can cost
200 times as much as treating the ordinary form of the disease.
"This is quite a milestone in the story of therapy for TB," Dr.
Paul Stoffels, the chief scientific officer at Johnson & Johnson,
said in an interview. He said it was the first time in 40 years that
the agency had approved a drug that attacked tuberculosis in a
different way from the current treatments on the market. Sirturo
works by inhibiting an enzyme needed by the tuberculosis bacteria to
replicate and spread throughout the body.
Sirturo, also known as bedaquiline, would be used on top of the
standard treatment, which is a combination of several drugs.
Patients with drug-resistant tuberculosis often must be treated for
18 to 24 months.
Even as it announced the approval, however, the F.D.A. also
issued some words of caution.
"Multidrug-resistant tuberculosis poses a serious health threat
throughout the world, and Sirturo provides much-needed treatment for
patients who have don't have other therapeutic options available,"
Edward Cox, director of the office of antimicrobial products in the
F.D.A.'s center for drug evaluation and research, said in a
statement.
"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," the statement
added.
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