The Food and Drug Administration approved on Wednesday a new drug for highly drug-resistant tuberculosis, the world's leading infectious cause of death.
Tuberculosis kills 1.6 million people a year, of which approximately 500,000 suffer from drug-resistant disease strains.
The antibiotic pretomanid was developed by the non-profit TB Alliance group at a time when few companies invest in the expensive and unprofitable endeavor to create something next-generation antibiotics.
Some researchers hope the TB Alliance can serve as a model for the development of antibiotics as health authorities warn of the growing threat of drug-resistant infections. According to the United Nations, such infections could cause 10 million deaths annually by 2050 if nothing is done.
eradication of a disease like TB, "said Mel Spigelman, president and chief executive officer of the TB Alliance.
Drug manufacturers have largely phased out the development of antibiotics because they can cost more than $ 1 billion to bring them to market, but generate far less revenue than drugs for chronic conditions such as high blood pressure and high cholesterol or specialty medications that can cost hundreds of thousands of dollars or more. Antibiotics are often cheap and taken for days or weeks, as opposed to anticancer and chronic illness taken months or even years.
All antibiotics approved in the past decade have generated disappointing sales, and Achaogen, a company that approved an antibiotic last year, filed for bankruptcy in April.
Pretomanid is part of a three-drug regime against highly resistant forms of TB and the third FDA-approved anti-TB drug for more than 40 years. TB Alliance reported that 95 of its first 107 patients in the clinical trial had achieved a successful outcome after six months of treatment with three drugs. The historical success rate for treatment is 34 percent.
Drug-resistant TB is currently being treated with countless medications and may require thousands of pills. According to the World Health Organization, more than 120 countries have been reported.
Bacterial infections develop resistance to the antibiotics used against them, which means that treatable infections, including some forms of tuberculosis, are extremely difficult to treat. Experts have warned of an impending post-antibiotic era in which many infections could become untreatable.
The TB Alliance hopes the FDA's approval will allow other countries, such as China, India and South Africa, to get the drug in order and make it available to its residents. The disease is highly contagious and spreads through coughing, sneezing or even talking.
In the New England Journal of Medicine this month, researchers and infectious disease physicians argued that the current model for developing antibiotics was broken, especially because there are only a few companies who do this to develop them to compete with each other, to develop medicines for the same infections. Instead, they suggest that nonprofit organizations, including the TB Alliance, play a bigger role as they are not exposed to pressure from shareholders to develop income-generating medicines.
Some experts say governments need to step up financial incentives for businesses. Such efforts by the US government have led to an increase in development – 42 antibiotics were in development in March 2019, compared to six in 2004 – but many of the drugs were unnecessary or have not tackled some of the most urgent threats The Pew Charitable trusts.
"TB is much narrower, more focused, and has a precedent in the nonprofit world," said Helen Boucher, professor of medicine at Tufts Medical Center and director of the Tufts Center for Integrated Management of Antibiotic Resistance. "Economists have told us and others that a nonprofit model would not be enough to meet the need for a robust and renewable pipeline in America."
The non-profit model is promising for neglected diseases and those that affect mainly the inhabitants in poorer regions, said Boucher.
"There is no market to sell [a TB drug] to make money, so it was essential for a non-profit organization to do it," said Boucher. "Any progress is good progress."