29 January 2015 - New Delhi, India -- On January 14, 2015, The Drugs Controller General of India (DCGI) approved SIRTURO® (bedaquiline) for use in adults (>18 years) as part of combination therapy of pulmonary tuberculosis due to multidrug-resistant Mycobacterium tuberculosis (MTR-TB), when an effective treatment regimen cannot otherwise be provided.
This approval is an exciting milestone in the fight against TB, and specifically MDR-TB which poses a significant treatment challenge and major public health concern in India. The World Health Organization (WHO) estimates that there are more than 2,800,000 cases of TB in India, and amongst those who carry the burden of TB, approximately 64,000 cases are suspected to be multidrug-resistant . Fewer than half of these cases are treated successfully.
SIRTURO® is a diarylquinoline antimycobacterial agent discovered and developed by Janssen scientists at the French R&D centre. The unique mechanism of action of SIRTURO® inhibits the mycobacterial adenosine 5'-triphosphate (ATP) synthase, an enzyme essential for the generation of energy in Mycobacterium tuberculosis. Due to its novel mechanism of action, SIRTURO® defines a new class of anti-TB compounds that is now available in India for the first time in several decades.
The treatment is being rolled out under the Revised National Tuberculosis Control Program (RNTCP) and will initially provide access to SIRTURO® through four to five public hospitals of national importance in the treatment of MDR-TB patients. Approximately 500 patients will have access to SIRTURO® in the first instance, and upon review of clinical data from these patients, the access program will be expanded nationwide.
Source: Stop TB Partnership