FDA
Aprueba el SIRTURO para el tratamiento de Tuberculosis Multirresistente
Fuente de la imagen
Fuente del texto: FDA
FDA NEWS RELEASE
For Immediate Release: Dec. 31, 2012
Media Inquiries: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
Media Inquiries: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
On
Dec. 28, the U.S. Food and Drug Administration approved Sirturo
(bedaquiline) as part of combination therapy to treat adults with
multi-drug resistant pulmonary tuberculosis (TB) when other alternatives
are not available.
TB is an infection caused by Mycobacterium
tuberculosis and is one of the world’s deadliest diseases. It is spread
from person to person through the air and usually affects the lungs, but
it can also affect other parts of the body such as the brain and
kidneys. According to the Centers for Disease Control and Prevention,
nearly 9 million people around the world and 10,528 people in the United
States became sick with TB in 2011.
Multi-drug resistant TB
occurs when M. tuberculosis becomes resistant to isonazid and rifampin,
two powerful drugs most commonly used to treat TB. Sirturo is the first
drug approved to treat multi-drug resistant TB and should be used in
combination with other drugs used to treat TB. Sirturo works by
inhibiting an enzyme needed by M. tuberculosis to replicate and spread
throughout the body.
“Multi-drug 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,” said Edward Cox, M.D., M.P.H, director of the
Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation
and Research. “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.”
Sirturo is being
approved under the FDA’s accelerated approval program, which allows the
agency to approve a drug to treat a serious disease based on clinical
data showing that the drug has an effect on a surrogate endpoint that is
reasonably likely to predict a clinical benefit to patients. This
program provides patients earlier access to promising new drugs while
the company conducts additional studies to confirm the drug’s clinical
benefit and safe use.
The FDA also granted Sirturo fast track
designation, priority review and orphan-product designation. The drug
demonstrated the potential to fill an unmet medical need, has the
potential to provide safe and effective treatment where no satisfactory
alternative therapy exists, and is intended to treat a rare disease,
respectively.
Sirturo carries a Boxed Warning alerting patients
and health care professionals that the drug can affect the heart’s
electrical activity (QT prolongation), which could lead to an abnormal
and potentially fatal heart rhythm. The Boxed Warning also notes deaths
in patients treated with Sirturo. Nine patients who received Sirturo
died compared with two patients who received placebo. Five of the deaths
in the Sirturo group and all of the deaths in the placebo arm seemed to
be related to tuberculosis, but no consistent reason for the deaths in
the remaining Sirturo-treated patients could be identified.
Sirturo’s
manufacturer, Janssen Therapeutics, will distribute the drug from a
single source and will provide educational materials to help ensure the
drug is used appropriately.
Sirturo’s safety and effectiveness
were established in 440 patients in two Phase 2 clinical trials.
Patients in the first trial were randomly assigned to be treated with
Sirturo plus other drugs used to treat TB, or a placebo plus other drugs
used to treat TB. All patients in the second trial, which is ongoing,
received Sirturo plus other TB drugs. Both studies were designed to
measure the length of time it took for a patient’s sputum to be free of
M. tuberculosis (sputum culture conversion, or SCC).
Results from
the first trial showed patients treated with Sirturo combination therapy
achieved SCC in a median time of 83 days, compared with 125 days in
patients treated with placebo combination therapy. Results from the
second trial showed the median time to SCC was 57 days, supporting the
efficacy findings of the first trial.
Common side effects identified in the clinical trials include nausea, joint pain, and headache.
Janssen Therapeutics, a division of Janssen Products LP, is based in Titusville, N.J.
For more information:
The
FDA, an agency within the U.S. Department of Health and Human Services,
protects the public health by assuring the safety, effectiveness, and
security of human and veterinary drugs, vaccines and other biological
products for human use, and medical devices. The agency also is
responsible for the safety and security of our nation’s food supply,
cosmetics, dietary supplements, products that give off electronic
radiation, and for regulating tobacco products.
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