Mylan Working With Drug Regulator To Launch New TB Drug In India
TB Alliance and Mylan had in Apil announced a global collaboration for pretomanid to treat drug-resistant pulmonary tuberculosis.
Mylan N.V. is working with the Drug Controller General of India to launch pretomanid, a medicine used to treat drug-resistant tuberculosis, a top official at the U.S. drugmaker said on Tuesday.
Not-for-profit drug developer TB Alliance and Mylan had in April announced a global collaboration to make the experimental drug to treat pulmonary tuberculosis. TB Alliance was advancing the development of pretomanid in three ongoing late-stage clinical trials, Mylan had said in April.
"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," Rajiv Malik, Mylan’s global president and executive director, said during his recent visit to India.
This drug is important for India because Prime Minister Narendra Modi said India would get rid of tuberculosis by 2025, he added.
The prime minister has launched a campaign to eradicate tuberculosis from India by 2025, five years ahead of a globally-set deadline.
Pretomanid is only the third new anti-TB drug approved for use by the U.S. Food and Drug Administration in more than 40 years and is the first to be developed and registered by a not-for-profit organisation.
Mylan expects the drug to be launched in the U.S. by the year-end, Malik said.
“The U.S. will be the first country in which the product will be launched, and we expect this to occur by the end of this year. In other countries with a high TB burden, Mylan is in the process of filing for registration of pretomanid with various regulatory authorities,” he added.
Tuberculosis continues to be one of the Top 10 causes of death worldwide and the leading infectious killer-disease. India has the world’s highest share (27 percent) of all TB cases at 2.7 million and accounted for nearly a third of all TB deaths globally in 2017. A total of 21.5 lakh TB cases was reported in 2018, an increase of 17 percent over 18 lakh in 2017, according to the Annual India TB Report for 2019 released recently, a Mylan spokesperson said.