On October 15, 2019, Mylan N.V. a pharmaceutical company announced to launch a pretomanid, a new TB drug used to treat drug-resistant tuberculosis in India. Mylan is working with the Drug Controller General of India to launch a pretomanid. In April 2019, Mylan and Not-for-profit drug developer TB Alliance collaborated to make the experimental drug to treat pulmonary tuberculosis. As per Mylan, TB Alliance was advancing the development of pretomanid in three ongoing late-stage clinical trials TB Al. Under the terms of the agreements comprising the collaboration and pending regulatory approvals, Mylan anticipates being the first company with the license to commercialize pretomanid for use in these regimens in certain low- and middle-income countries, where the vast majority of the global TB burden is located.
Mylan’s global president and executive director said “we have submitted new drug application to the office of DCGI. We are in an advanced stage of discussion and are working with the office of DCGI. Mylan will be in a position to launch the product in India soon after receiving approvals from DCGI”.
Along with it, Prime Minister Narendra Modi said: “This drug is important for India and would get rid of tuberculosis by 2025”.
Pretomanid is only 3rd new anti-TV drug approved by the US FDA in more than 40 years and is the first to be developed and registered a not-for-profit organization.
The US will be the first country in which new anti-TV drug will be launched by year-end. In other countries with a high TB burden, Mylan is in the process of filing for registration of pretomanid with various regulatory authorities. India has the world’s highest share (27%) of all TB cases at 2.7 million and accounted for nearly a third of all TB deaths in 2017. A total of 21.5 lacs TB cases was reported in 2018, an increase of 17% over 18 lacs in 2017, as per the Annual India TB Report for 2019 released recently, Mylan is projected to launch pretomanid in India.
