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Source: http://www.voanews.com/content/us-fda-approves-drug-resistant-tuberculosis-treatment/1576056.html
US Approves Drug-Resistant Tuberculosis Treatment
VOA News
January 01, 2013
The U.S. Food and Drug Administration has approved a new medication for treating multi-drug resistant tuberculosis (MDR-TB).
Sirturo, known chemically as bedaquiline, is the first new anti-TB therapy approved in more than 40 years. It is also the first designed as part of a combination therapy to treat adults infected with drug-resistant pulmonary TB, when other treatments are unavailable. The new drug works by blocking an enzyme the disease pathogen needs to spread throughout the body.
Developed by Janssen Therapeutics, a division of U.S. drugmaker Johnson & Johnson, Sirturo was approved under the FDA?s accelerated review program that allows promising drugs to be brought to market more quickly.
The federal agency cautions that the medication carries risks of potentially deadly heart problems, and advises doctors to prescribe and administer Sirturo carefully. A consumer health group, Public Citizen, criticized the FDA?s accelerated review of bedaquiline, saying its apparent toxicity ?means an increased level of scrutiny should be required for its approval...?
US Approves Drug-Resistant Tuberculosis Treatment
VOA News
January 01, 2013
The U.S. Food and Drug Administration has approved a new medication for treating multi-drug resistant tuberculosis (MDR-TB).
Sirturo, known chemically as bedaquiline, is the first new anti-TB therapy approved in more than 40 years. It is also the first designed as part of a combination therapy to treat adults infected with drug-resistant pulmonary TB, when other treatments are unavailable. The new drug works by blocking an enzyme the disease pathogen needs to spread throughout the body.
Developed by Janssen Therapeutics, a division of U.S. drugmaker Johnson & Johnson, Sirturo was approved under the FDA?s accelerated review program that allows promising drugs to be brought to market more quickly.
The federal agency cautions that the medication carries risks of potentially deadly heart problems, and advises doctors to prescribe and administer Sirturo carefully. A consumer health group, Public Citizen, criticized the FDA?s accelerated review of bedaquiline, saying its apparent toxicity ?means an increased level of scrutiny should be required for its approval...?