The Food and Drug Administration has approved a new antibiotic for a form of drug-resistant tuberculosis developed by a nonprofit organization, under a pathway meant to spur development of much-needed new antimicrobial drugs.
The FDA said Wednesday that it had approved pretomanid, for treating a type of treatment-resistant tuberculosis in the lungs. In addition to being a treatment for an antibiotic-resistant infection, the drug is the product of a nonprofit organization, the Global Alliance for TB Drug Development, or the TB Alliance. It’s also the second drug to win approval under the Limited Population Pathway for Antibacterial and Antifungal Drugs, or LPAD, part of the 21st Century Cures Act.
The approval was based on a study of 109 patients with extensively drug-resistant TB. Of the 107 who were evaluable, 89 percent were successfully treated, which exceeds the historical success rate for the disease, according to the FDA.
Based in New York, the TB Alliance’s board of directors includes former drug industry executives and officials from international organizations like the World Bank and World Health Organization. Its donors range from non-profit organizations like the Bill & Melinda Gates Foundation and Cystic Fibrosis Foundation to government agencies in the U.S., Australia, Europe and Asia.
The first drug approved under LPAD was Insmed’s inhaled Arikayce (amikacin liposome), for lung disease caused by Mycobacterium avium complex, or MAC bacteria. That approval was given in September 2018.
“The threat of antimicrobial-resistant infections is a key challenge we face as a public health agency,” said Amy Abernethy, the FDA’s principal deputy commissioner, in a statement. “The bacterium that causes tuberculosis can develop resistance to the antibiotics used to treat it.”
Pretomanid is meant to be taken in combination with two other drugs, bedaquiline and linezolid. According to World Health Organization statistics cited by the FDA, there were an estimated 490,000 new cases of multidrug-resistant TB worldwide in 2016. Drug-resistant TB resulted in an estimated 240,000 deaths that same year, according to the WHO, with the percentage of cases highest in Russia and other countries in the former Soviet Union, as well as China and parts of South America, the Middle East and North Africa.
Broadly, drug-resistant bacteria present a global problem that has led to apocalyptic predictions of life in a “post-antibiotic era” where even a simple knee scrape can kill. But a major part of why developing new antibiotics is so difficult is not scientific, but economic. Developing the drugs is simply not profitable for the most part, as indicated by high-profile company failures like the bankruptcy of Achaogen. In response, some experts have said a nonprofit model for development may provide a long-term solution.
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