TB Alliance Applauds Macleods’ Launch of a Key Component of WHO-Recommended Drug-Resistant TB Treatment Regimen

Macleods becomes second pharmaceutical manufacturer to bring pretomanid supply to market and first since the World Health Organization issued updated DR-TB treatment guidelines

November 13, 2023

NEW YORK (November 13, 2023)—Indian pharmaceutical company Macleods has become the second manufacturer to launch pretomanid, a new medicine and essential component of shortened, World Health Organization (WHO)-recommended treatment regimens for drug-resistant tuberculosis (DR-TB). Under license from TB Alliance, Macleods will be able to supply to 135 low- and middle-income countries. Macleods has recently commenced supplying pretomanid to the Stop TB Partnership's Global Drug Facility for distribution of the medicine to those countries.

Pretomanid was developed by the nonprofit TB Alliance, as part of the all-oral, six-month BPaL (bedaquiline + pretomanid + linezolid) regimen used with or without moxifloxacin (BPaL/M). BPaL drastically reduces the time it takes to cure drug-resistant TB, with fewer side effects. Previously, drug-resistant TB treatment lasted 9 to 18 months or longer and often required people to take up to 14,000 pills over the course of treatment. BPaL is the first set treatment regimen recommended to treat drug-resistant TB. Now, more than 70 countries are procuring pretomanid and are in various stages of adopting and implementing the BPaL regimens.

“Ensuring a steady supply of high-quality products is critical for countries to scale up new TB treatments and to ensure people in need receive them. Macleods’ pretomanid product will create an additional source of pretomanid for countries, thereby making the BPaL regimen even more accessible,” said Sandeep Juneja, Senior Vice President of Market Access at TB Alliance. “We are glad to have Macleods, one of the longest-standing players in the TB medicines business, as a partner in our goal to help improve access to treatments for people with drug-resistant TB globally. Macleods is one of five commercial partners TB Alliance has collaborated with to ensure availability and affordability of pretomanid worldwide.”

“Producing medicines like pretomanid and making them available to patients across the globe is a central part of our mission,” said Vijay Agarwal, CEO of Macleods. “Curing drug-resistant TB faster and with fewer pills will help people overcome one of the most difficult-to-treat infections on our planet. We are proud of our relationship with TB Alliance and feel privileged to be bringing pretomanid, a life-saving new medication, to the market.”

According to the World Health Organization, an estimated 450,000 people developed DR-TB in 2021. However, only about 1 in 3 people with drug-resistant TB accessed treatment. The availability of Macleods’ product to 135 countries will improve access in many of the countries with high burdens of DR-TB infections.

TB Alliance has previously collaborated with Macleods on the introduction of child-friendly formulations of first-line TB medicines. Since that launch in 2015, more than 1.8 million treatment courses have been supplied to 125 countries.



About TB Alliance

TB Alliance is a not-for-profit organization dedicated to finding faster-acting and affordable drug regimens to fight TB. Through innovative science and with partners around the globe, we aim to ensure equitable access to faster, better TB cures that will advance global health and prosperity. TB Alliance operates with support from Australia’s Department of Foreign Affairs and Trade, Bill & Melinda Gates Foundation, Foreign, Commonwealth and Development Office (United Kingdom), Cystic Fibrosis Foundation, Germany’s Federal Ministry of Education and Research through KfW, Global Disease Eradication Fund (South Korea), Global Health Innovative Technology Fund, Irish Aid, Korea International Cooperation Agency, National Institute of Allergy and Infectious Diseases, South Korea’s Ministry of Foreign Affairs, Unitaid, and the United States Agency for International Development. For more information, please visit: www.tballiance.org.


About Macleods Pharmaceuticals Limited

Macleods is a vertically integrated generic pharmaceutical company, highly focused on essential medicines, which are needed for treatment of TB, HIV and Malaria. With supplies made in over 140 countries, our geographical presence ensures that we are able to respond to medical needs in most of the high burden countries. We remain true to our mission to provide affordable care to patients, worldwide.