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Member Research and Reports

UNC: FDA Approves Breakthrough Drug to Treat Extensively Drug-Resistant Tuberculosis

In August, the U.S. Food and Drug Administration (FDA) announced its approval of pretomanid, a new drug developed to treat Extensively Drug-Resistant Tuberculosis (XDR-TB) and treatment intolerant/non-responsive Multidrug-Resistant TB.

Research Triangle Institute (RTI) International scientist and University of North Carolina Gillings School of Global Public Health adjunct professor Dr. Doris Rouse and her team have collaborated closely with the Tuberculosis (TB) Alliance on the development of pretomanid for almost 20 years.

“We are seeing an increase in XDR-TB, and we need new weapons to attack it,” Dr. Rouse says. “I’ve been in wards with patients who are so emaciated, they won’t eat anything, they have fevers, they can’t sleep. But with pretomanid, in a regimen that includes two other drugs, bedaquiline and linezolid, we see improvement within a few weeks.”

Tuberculosis kills 1.6 million people a year — more than 4,000 people a day — and more than any other infectious disease. XDR-TB is resistant to four of the main drugs, including injectable agents, which currently are used to treat drug-resistant TB around the world.

Pretomanid is only the third anti-TB drug approved by the FDA in more than 40 years. Prior to the pivotal Nix-TB trial of pretomanid as part of a three-drug regimen with bedaquiline and linezolid (known as the BPaL regimen), treatment for XDR-TB required a two-year regimen and, in South Africa, for example, only cured 2 to 22 percent of those receiving treatment. The six-month, all-oral BPaL regimen cured approximately nine out of 10 participants.

“We’ve worked on this new drug for 19 years, and it hasn’t always been an easy path,” Dr. Rouse says. “But, as I’ve always said: ‘One of the main ingredients for successful drug development is blessed stubbornness.’”

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