Mylan gets DCGI approval for tuberculosis drug pretomanid

July 23, 2020 0 By FM

Drugmaker Mylan has announced that the company has received the approval from the Drug Controller General of India to make tuberculosis treatment pretomanid available in the for conditional access under the National Tuberculosis Elimination Program (NTEP).

Mylan will initially make a donation of 400 treatment courses of pretomanid under the Indian government’s NTEP programme which provides free, quality anti-tubercular drugs and care across the country to the patients who need it the most.

The company will also provide commercial access to NTEP at $364 for a six-month treatment course, the company said. Mylan will be manufacturing pretomanid both for domestic and global supply in India.

Pretomanid has been approved as part of a three-drug, six-month all-oral regimen for the treatment of adult patients with pulmonary extensively drug-resistant TB (XDR-TB), treatment intolerant or non-responsive multidrug-resistant TB (MDR-TB). The three-drug combination collectively referred to as “BPaL” consists of bedaquiline, pretomanid and linezolid.

According to the World Health Organization, between 2020 and 2025, an additional 1.4 million tuberculosis deaths could be registered as a direct consequence of the COVID-19 pandemic.

Tuberculosis is one of the leading causes of mortality in India, killing more than 300,000 people in the country every year, according to the Central Tuberculosis Division set up by the nation’s health ministry.

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.

Pretomanid as part of the three-drug combination was approved by the US Food and Drug Administration in August 2019. India is the second country to provide regulatory approval for this drug.