Pretomanid, one of the new medicines to treat drug-resistant tuberculosis may soon be available to Indian patients.
Mylan, a leading generic drug maker, is working with Drug Controller General of India (DCGI) to launch pretomanid, reports The Economic Times.
Pretomanid, developed by the non-profit TB Alliance, has received U.S. approval in a combination regimen with bedaquiline and linezolid for people with XDR-TB or treatment-intolerant or non-responsive MDR-TB in August.
Mylan NV and TB Alliance had in April announced a global collaboration on pretomanid.
Mylan already submitted the new drug application to the office of DCGI and was in advanced stage of discussion. The company would launch the product in India soon after receiving approvals from DCGI, the report said quoting senior officials from Mylan
Pretomanid is a new chemical entity and a member of a class of compounds known as nitroimidazooxazines. TB Alliance acquired the developmental rights to the compound in 2002. It has been developed as an oral tablet formulation for the treatment of pulmonary TB
Mylan expects the drug to be launched in USA during this year-end.
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 in 2017. A total of 21.5 lakh TB cases was reported in 2018, an increase of 17 percent over 18 lakh in 2017, as per the Annual India TB Report for 2019 released recently.