Fast-track approval for treatment of tuberculosis
May 3, 2013
Bedaquiline (Sirturo) represents a new class of anti-TB drugs called diarylquinolines that have a novel mechanism of action to stop replication of TB. It has FDA approval for treatment of multi-drug resistant pulmonary TB. The drug has not been evaluated with extra-pulmonary TB affecting the CNS. Standard treatment involves a four-drug regimen with isoniazid, rifampin and pyrazinamide (PZA). A recent meta-analysis showed the percentage of patients dying from TB was 3% in non-HIV patients, 9.2% in HIV-infected patients and 30.9% in HIV-infected patients with multi-drug resistant TB. This drug achieved fast-track approval by the FDA due to risks associated with multi-drug resistant TB.
Recent clinical trials included patients with pulmonary TB and used the same dosing strategy (400 mg orally twice daily for two weeks followed by 200 mg three times per week). The clinical endpoint was the time to…
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