NEW YORK (November 6, 2024) — Macleods, a pharmaceutical company headquartered in India, has received prequalification from the World Health Organization (WHO) for its 200mg tablet of pretomanid, which provides an assurance of safety, quality and efficacy for drug-resistant tuberculosis (DR-TB) patients and their healthcare providers.
Pretomanid was developed by the nonprofit TB Alliance and is a key component of the BPaL/M regimens, which have shortened the time needed to treat DR-TB to six months. Previously, most DR-TB treatment regimens lasted 9-18 months or sometimes longer.
By partnering with Macleods and other predominantly generic manufacturers, TB Alliance aims to expand access to this life-saving treatment through a strategic commercialization approach – helping to deliver on our commitment to ensure an affordable, sustainable and competitive market for all our new TB products. Macleods has agreed to commercialize pretomanid in approximately 140 countries and territories.
According to new data from the WHO, an estimated 400,000 people developed DR-TB infections in 2023, with only 176,000 people starting treatment. TB is the world’s deadliest infectious disease. Macleods' new product will accelerate our continued efforts to reliably provide more patients with access to this life-saving regimen.
WHO prequalification is a standard for medical products required for procurement by many UN agencies, multilateral organizations like the Global Fund and Stop TB’s Global Drug Facility for supplying low- and middle-income countries. By obtaining WHO pre-qualification for pretomanid, Macleods will be able to service demand for this life saving medicine from these agencies.