AUG 19, 2019 9:36 AM PDT

FDA Approves New Treatment for Extensively Drug-Resistant TB

WRITTEN BY: Tiffany Dazet

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.

Sources: FDA, RTI, Nature
 

About the Author
  • Tiffany grew up in Southern California, where she attended San Diego State University. She graduated with a degree in Biology with a marine emphasis, thanks to her love of the ocean and wildlife. With 13 years of science writing under her belt, she now works as a freelance writer in the Pacific Northwest.
You May Also Like
JAN 15, 2020
Health & Medicine
JAN 15, 2020
The "Normal" Body Temperature Has Decreased
Did you know that the standard human body temperature of 98.6 degrees Fahrenheit was established in 1868? A few modern studies have called this figure into...
JAN 16, 2020
Cannabis Sciences
JAN 16, 2020
College Kids Exchange Alcohol for Weed in Legal States
Researchers have now found that legalization of marijuana has significantly increased the number of college-aged pot smokers, while significantly decreased...
JAN 28, 2020
Genetics & Genomics
JAN 28, 2020
Developing a Gene Therapy to Treat Duchenne Muscular Dystrophy
Because of a genetic mutation, people that have Duchenne muscular dystrophy lack functional copies of a protein called dystrophin....
JAN 29, 2020
Cannabis Sciences
JAN 29, 2020
In Sicily, Medical Cannabis Is Now Free
The Sicilian government will now foot the bill for many patients using medical cannabis. Sicily’s top health administrator, Ruggero Razza, announced...
FEB 06, 2020
Health & Medicine
FEB 06, 2020
Scientists Found a Safe BPA Alternative
BPA—bisphenol A—is an industrial chemical used in a wide range of everyday consumer products. From food and beverage can linings and storage co...
FEB 14, 2020
Microbiology
FEB 14, 2020
Beneath the Surface, We All Carry the Same Microbes in Our Skin
Our skin is a critical barrier, and it is made up of three layers. It also carries a community of microbes - a skin microbiome....
Loading Comments...