Last week, the U.S. Food and Drug Administration (FDA) approved a new treatment for a severe form of multi-drug-resistant tuberculosis of the lungs. According to a press release from the FDA, the treatment consists of a six-month regimen of pretomanid tablets combined with bedaquiline and linezolid—referred to as the BPaL regimen. This is one of three tuberculosis treatments to gain FDA approval in the past 40 years. During clinical trials, about 90% of participants using this treatment recovered within six months.
It’s estimated that 1.6 million people die from tuberculosis every year, killing more than any other infectious disease. An article in Nature states that half a million people worldwide are diagnosed with multi-drug-resistant tuberculosis every year. Of those, 8.5% have XDR TB—extensively drug-resistant tuberculosis—which according to RTI, is resistant to four of the main tuberculosis treatments currently in use worldwide. Mel Spigelman, president of the TB Alliance, told Nature “drug-resistant TB is the largest single source of antimicrobial resistance in the world.”
Pretomanid was developed by RTI International as part of the TB Alliance, which is a non-profit product development partnership established in 2000. The team was led by Dr. Doris Rouse, as RTI International scientist. In a statement from RTI, Dr. Rouse said “I’ve been in wards with patients that are so emaciated, they won’t eat anything, they have fevers, they can’t sleep. But with pretomanid, in a regimen that contains two other drugs, bedaquiline and linezolid, we see improvement within a few weeks.”
The development of pretomanid took nearly 20 years. Dr. Rouse commented, “We’ve worked on this new drug for 19 years and it hasn’t always been an easy path. But as I’ve always said, ‘One of the main ingredients for successful drug development is blessed stubbornness.’”
Affordable pricing will be a major hurdle to make the treatment accessible to impoverished patients. According to Sharonann Lynch, the TB advisor for Doctors Without Borders, only 20% of those who needed bedaquiline were able to afford it. Nature states that a six-month supply of bedaquiline and delaminid can cost hundreds to thousands of dollars. The price of the new treatment is currently under negotiations by the TB Alliance.