DCGI Approves Mylan in India for Tuberculosis Drug

National Tuberculosis Elimination Program (NTEP) program, making India the second country in the world to provide regulatory approval for this product.

Picture: Pixabay

BANGALORE Mylan, a global pharmaceutical company, today 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.

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Mylan President Rajiv Malik said, “The approval of pretomanid in India 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.”. He further added,” To date, Mylan and TB Alliance have secured approvals for pretomanid in two countries. We look forward to continuing our journey to ensure the availability of treatment for those who most need it in high-burden countries globally.”

India accounts for approximately a quarter of the world’s TB burden, with an estimated 2.7 million cases per year, 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. 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.

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