Published online May 26, 2013. doi: 10.13105/wjma.v1.i1.8
Revised: February 22, 2013
Accepted: March 6, 2013
Published online: May 26, 2013
Processing time: 113 Days and 18 Hours
Tuberculosis (TB) is an infection caused by Mycobacterium tuberculosis and is one of the world’s deadliest diseases. Multidrug resistant TB (MDR-TB) is a serious form of TB and it implies resistance for at least two essential first-line agents like, Isoniazid and Rifampicin. The US Food and Drug Administration (FDA) granted accelerated approval to Janseen Therapeutics “Sirturo (Bedaquiline)”, a diarylquinoline anti mycobacterial drug on December 28, 2012 as part of combination therapy in adults (≥ 18 years) to treat MDR-TB when other alternatives are not available. The FDA also granted Sirturo fast track designation, priority review and orphan-product designation. Bedaquiline inhibits mycobacterial ATP (adenosine 5’-triphosphate) synthase, an enzyme that is essential for the generation of energy in Mycobacterium tuberculosis.
Core tip: The US Food and Drug Administration granted accelerated approval to Janseen Therapeutics “Sirturo (Bedaquiline)”, a diarylquinoline anti mycobacterial drug on December 28, 2012 as part of combination therapy in adults (≥ 18 years) to treat multidrug resistant tuberculosis when other alternatives are not available.