Mylan Gets Indian Regulatory Approval for Tuberculosis Drug
Drugmaker Mylan NV said on Wednesday it has received Indian regulatory approval to make tuberculosis treatment pretomanid available in a country that accounts for a quarter of the world’s cases.
Mylan will initially make a donation of 400 treatment courses of pretomanid under the Indian government’s National Tuberculosis Elimination Program (NTEP) and will provide commercial access at $364 for a six-month treatment course.
“The Drug Controller General of India has approved the anti-tuberculosis drug pretomanid for conditional access under the NTEP,” Mylan said to Reuters in an emailed statement.
New treatments against tuberculosis have been sparse, with pretomanid being only the third new drug developed for drug-resistant forms of the disease to be approved in more than 40 years, after Johnson & Johnson’s bedaquiline and Otsuka Pharmaceutical Co Ltd’s delamanid.
The approval comes amid fears the coronavirus outbreak has derailed global efforts to curtail the spread of tuberculosis, a bacterial infection that mainly affects a patient’s lungs.
Between 2020 and 2025, an additional 1.4 million tuberculosis deaths could be registered as a direct consequence of the COVID-19 pandemic, the World Health Organization said.
Pretomanid has been approved as part of a three-drug, six-month all-oral regimen for the treatment of highly drug-resistant forms of tuberculosis. The three-drug combination also consists of linezolid and J&J’s bedaquiline.
Not-for-profit TB Alliance granted a non-exclusive license to Mylan to manufacture and sell pretomanid in April last year. Pretomanid as part of the three-drug combination was approved by the U.S. Food and Drug Administration in August last year.
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