India has become the second country in the world to provide DCGI approval for anti-tuberculosis drug pretomanid for conditional access under the National Tuberculosis Elimination Program (NTEP) programme.
Pretomanid has been approved as part of a three-drug, six-month all-oral regimen consisting of bedaquiline, pretomanid and linezolid, collectively referred to as “BPaL” for treatment of adult patients with pulmonary extensively drug-resistant TB (XDR-TB), treatment intolerant or non-responsive multidrug-resistant TB (MDR-TB).
The drug manufacture, Mylan will initially make its pretomanid available in India through a donation of 400 treatment courses to the NTEP which provides free, high quality anti-tubercular drugs and care across the country to ensure that the treatment is accessible to patients who need it the most.
Mylan president Rajiv Malik said, “To date, Mylan and TB Alliance have secured approvals for pretomanid in two countries” while president and CEO of TB Alliance Mel Spigelman, said, “The approval of pretomanid in India as part of this three-drug, all-oral regimen is the first in a country with a high TB burden. By embracing innovation, India has an opportunity to lead the charge to end TB and meet its ambitious goals for eradication.”
India has the goal of TB elimination by 2025.
India accounts for approximately a quarter of the world’s TB burden, with an estimated 2.7 million cases per year, highest for any country, globally. Of these, around 130,000 patients have some form of drug-resistant TB.
Patients frequently face complicated and lengthy treatment regimens of up to 20 months which often result in poor clinical outcomes. The WHO has reported treatment success rates of 48% for MDR-TB and 30% for XDR-TB in India.