Mylan receives DCGI approval in India for TB drug, Pretomanid

Mylan announced that the Drug Controller General of India (DCGI) has approved the anti-tuberculosis drug pretomanid for conditional access under the National Tuberculosis Elimination Program (NTEP) program, making India the second country in the world to provide regulatory approval for this product. Pretomanid has been approved as part of a three-drug, six-month all-oral regimen (with option to extend treatment to nine months in certain conditions) consisting of bedaquiline, pretomanid and linezolid, collectively referred to as “BPaL” for the treatment of adult patients with pulmonary extensively drug-resistant TB (XDR-TB), treatment intolerant or non-responsive multidrug-resistant TB (MDR-TB).

Through the conditional access approval from DCGI, Mylan will initially make its pretomanid available in India through a donation of 400 treatment courses to the Government’s National Tuberculosis Elimination Program (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. The company also will provide commercial access to NTEP at the previously announced “global access price” of US $364 for a six-month treatment course, and will be manufacturing its pretomanid product both for domestic and global supply in India.

Mylan President Rajiv Malik said, “Mylan offers one of the world’s leading infectious disease portfolios and the approval of pretomanid in India further supports our global commitment to transform the TB treatment landscape through greater access and affordability. It also demonstrates the power of innovative partnerships, like the one we’re proud to have with TB Alliance, in expanding the availability of new medicines for patients. To date, Mylan and TB Alliance have secured approvals for pretomanid in two countries. As important, and thanks to DCGI’s continued focus on the treatment of TB even amidst the evolving COVID-19 pandemic, we achieved the approval in India with record speed. We look forward to continuing our journey to ensure the availability of treatment for those who most need it in high-burden countries globally.”

Rakesh Bamzai, President, India and Emerging Markets said, “This is a major milestone for Mylan in providing XDR-TB/MDR-TB patients with increased access to treatment and accelerating TB elimination in India by 2025, thereby transforming the TB treatment landscape in the country. With the DCGI approval of pretomanid in India, we continue our mission and commitment to ensure affordable and sustainable access to new TB treatments and other critical medicines for vulnerable patients in high burden countries like India.”

President and CEO of TB Alliance Mel Spigelman, M.D. said, “TB Alliance is committed to developing and introducing new treatments for patients with TB, including highly drug-resistant forms of this deadly disease. 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. We have developed this treatment as a non-profit organization funded by governments, foundations and individuals, and this approval underscores the promise of alternative approaches to antibiotic development. The rate of progress is encouraging and gives hope that we can meet our goal of ensuring this new treatment is accessible to every patient who needs it.”

India accounts for approximately a quarter of the world’s TB burden, with an estimated 2.7 million cases per year,[1] the highest for any country, globally. Of these cases, an estimated 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 World Health Organization has reported treatment success rates of 48% for MDR-TB and 30% for XDR-TB in India.[2]

In April 2019, Mylan and TB Alliance announced a global collaboration to make pretomanid accessible for use in two investigational drug regimens for pulmonary tuberculosis. The collaboration includes a global license from TB Alliance to Mylan for pretomanid for use in the BPaL and BPaMZ (bedaquiline, pretomanid, moxifloxacin and pyrazinamide) regimens across many low and middle-income countries.

The BPaL regimen was studied in TB Alliance’s Nix-TB trial, which demonstrated a favourable outcome in 90% of patients, as published in the 5 March 2020 issue of the New England Journal of Medicine. 11 patients (10%) had an unfavorable outcome and 98 patients (90%; 95% confidence interval, 83 to 95) had a favorable outcome. The primary efficacy endpoint for the study was the incidence of an unfavorable outcome defined as treatment failure (bacteriologic or clinical) or disease relapse through follow-up until 6 months after the end of treatment.