The prestigious award is the result of years of research and development by TB Alliance and partners
RESEARCH TRIANGLE PARK, N.C. — Pretomanid, a new treatment for extensively drug-resistant tuberculosis (XDR-TB) and intolerant/non-responsive multidrug-resistant (MDR) TB, was recently named the 2020 Prix Galien "Best Pharmaceutical Agent" by the Prix Galien USA Committee. The drug was developed by TB Alliance, a nonprofit product development partnership, with the support of RTI International and other partners.
The Prix Galien is a prestigious international award that recognizes outstanding achievements in improving the human condition through the development of innovative therapies.
“This is a humbling recognition for everyone who contributed to the efforts to develop pretomanid,” said Doris Rouse, Ph.D., Vice President of Global Health Technologies of RTI who was involved in the drug’s development from its beginning stages 20 years ago. “I’ve always said that one of the main ingredients for successful drug development is ‘blessed stubbornness.’ Pretomanid was no exception.”
TB Alliance acquired the license to pretomanid, then known as Pa-824, in 2002. RTI assisted TB Alliance in planning and managing the preclinical studies needed for development and preparing the successful Investigational New Drug (IND) application to U.S. Food and Drug Administration in 2005, leading to the start of clinical trials that year.
Pretomanid is used as part of a three-drug regimen with bedaquiline and linezolid (known as the BPaL regimen). A six-month, all-oral BPaL regimen cured approximately 9 out of 10 participants of the XDR-TB patients in the trials conducted in South Africa, paving the way for FDA approval in August 2019.
TB kills 1.4 million people a year — close to 4,000 people a day — and kills more people than any other infectious disease. XDR-TB is resistant to four of the main drugs, including injectable agents, that have been used to treat drug-resistant TB around the world.
For more information about the 2020 Prix Galien Award recipients, click here.
Read more about Dr. Rouse and her team’s work to bring pretomanid to market in this Impact Story.