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View Full Version : FDA Approval of SIRTURO™ for Multi-drug Resistant Tuberculosis (MDR-TB)



Janis.Y.Chen
Sat 19th January '13, 6:00pm
FDA Approval of SIRTURO™ for Multi-drug Resistant Tuberculosis (MDR-TB)

January 15, 2013

On December 28th, 2012 the FDA approved SIRTURO™ (bedaquiline) tablets for the treatment of pulmonary multi-drug resistant tuberculosis (MDR-TB), as part of combination therapy in adults (≥ 18 years). SIRTURO™ was approved under the accelerated approval regulations (21 CFR 314.500; Subpart H), using a surrogate efficacy endpoint of microbiological conversion of sputum cultures for M. tuberculosis from positive to negative.

SIRTURO™ is to be used where treatment alternatives are not available and when the benefits of treatment outweigh the risks. SIRTURO™ is available as 100 mg immediate release tablets. The recommended dosing regimen is 400 mg once daily for 2 weeks, followed by 200 mg 3 times per week for 22 weeks with food. SIRTURO™ should only be used in combination with at least 3 other drugs to which the patient’s MDR-TB isolate has been shown to be susceptible in vitro.

Bedaquiline is a diarylquinoline and has a unique mechanism of action involving specific inhibition of mycobacterial adenosine 5'-triphosphate (ATP) synthase, an enzyme that is essential for the generation of energy in mycobacteria.

Detail prescription information from FDA is at http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/204384s000lbl.pdf

http://dailymed.nlm.nih.gov/dailymed/image.cfm?id=85527&type=img&name=sirturo%2D03.jpg