One Year Since U.S. Approval, Accelerating Access to New TB Therapy
PRETORIA — Today marks the one year anniversary of the US FDA’s approval of pretomanid as part of the BPaL regimen for the treatment of adult patients with extensively drug-resistant TB (XDR-TB) or multidrug-resistant pulmonary TB (MDR-TB) that is treatment-intolerant or nonresponsive. Pretomanid is an anti-TB drug which has been developed by TB Alliance, a non-profit product development partnership dedicated to improving treatment of tuberculosis (TB).
Over this past year, TB Alliance and partners have worked to accelerate the global approval and accessibility of this new tool to appropriate patients in the fight against TB. Highlights in the effort to expand global access to pretomanid over the past year include:
Pretomanid was made available for 150 low and middle-income counties though Stop TB Partnership’s Global Drug Facility (GDF), a mechanism for the procurement of TB therapies, at a price of $364 for a six-month treatment course.
To facilitate global coverage of TB markets and to further promote competitive and sustainable pricing of the new regimen, TB Alliance reached commercialization agreements with additional manufacturing partners: Macleods, and Hongqi Pharma.
TB Alliance’s global commercialization partner Mylan established a Named Patient Access Program (NPAP) as a means of providing access to pretomanid as part of the three-drug, all-oral BPaL regimen in advance of national regulatory approvals.
New guidelines issued by the World Health Organization recommended the BPaL regimen under operational research conditions.
Enrollment was completed in TB Alliance’s phase 3 ZeNix and SimpliciTB clinical trials evaluating pretomanid-containing regimens, with results on safety and efficacy of these therapies expected in 2021. The 24-month follow-up on all patients in the pivotal Nix-TB trial was also completed.
In India, pretomanid has been granted DCGI approval for conditional access under the National Tuberculosis Elimination Program.
Pretomanid has received European Commission marketing authorization, in combination with bedaquiline and linezolid, for treating adults with XDR-TB or treatment-intolerant/non-responsive MDR-TB.
“We are encouraged by this rapid progress toward access and broad-based product introduction,” said Mel Spigelman, MD, President and CEO, TB Alliance. “We want to get these medicines into the hands of the patients who need them as soon as possible.”
About TB Alliance (Global Alliance for TB Drug Development)
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, Cystic Fibrosis Foundation, European & Developing Countries Clinical Trials Partnership, Germany’s Federal Ministry of Education and Research through KfW, Global Health Innovative Technology Fund, Indonesia Health Fund, Irish Aid, Medical Research Council (United Kingdom), National Institute of Allergy and Infectious Disease, Netherlands Ministry of Foreign Affairs, Rockefeller Foundation, United Kingdom Department for International Development, and the United States Agency for International Development.