The US Food and Drug Administration (FDA) on Wednesday approved a new drug against highly resistant tuberculosis, the leading cause of infectious death in the world.
Tuberculosis kills 1.6 million people a year, of whom about 500,000 suffer from drug-resistant strains of the disease.
The antibiotic, called pretomanid, was developed by a nonprofit group called TB Alliance at a time when few companies were investing in the costly and unprofitable effort of creating next-generation antibiotics .
Some researchers hope that TB Alliance can serve as a model for the development of antibiotic drugs, as health officials warn of the growing risk of drug-resistant infections. The United Nations predicted that such infections could cause 10 million deaths each year by 2050 if nothing is done.
"We can have a huge impact on the lives of people who are suffering and take a big step towards eradicating a disease like TB," said Mel Spigelman, TB Alliance President and CEO. .
"One of the obvious advantages of a non-profit organization is that you do not have to worry about making your profits to your shareholders."
Pharmaceutical companies have largely abandoned the development of antibiotics as they can cost more than a billion dollars to market, but report much less than drugs for the treatment of chronic diseases, such as high blood pressure and high blood pressure. Hypercholesterolemia, or specialized drugs that can reap hundreds of thousands of dollars or more in income per dose.
Antibiotics are often inexpensive and are taken for days or weeks, while cancer drugs and chronic diseases are taken for months or years.
Sales of antibiotics approved over the past decade have been disappointing and Achaogen, a company that had approved an antibiotic last year, filed for bankruptcy in April.
Pretomanid is part of a three-drug regimen against highly resistant forms of tuberculosis and is the third FDA-approved anti-TB drug in over 40 years. TB Alliance reported that 95 of the first 107 patients in its clinical trial had a positive result after six months of treatment with the three-drug regimen. The historical success rate of treatment is 34%.
Drug-resistant TB is treated with a myriad of medications and may require thousands of pills. It has been reported by more than 120 countries, according to the World Health Organization.
Bacterial infections develop resistance to the antibiotics used against them, which means that single-treatment infections, including some forms of tuberculosis, have become extremely difficult to treat. Experts have warned of the post-antibiotic era that is coming up, where many infections may no longer be treatable.
TB Alliance said hope the FDA approval would allow other countries, such as China, India and South Africa, to accept the drug and to make it available to its residents. The disease is very contagious and spreads by coughing, sneezing or even conversation.
in the New England Journal of Medicine this month, researchers and infectious disease physicians said the current model of antibiotic development was in shambles, especially because the few companies that developed them competed to develop drugs for same infections.
Instead, they suggest that non-profit organizations, including TB Alliance, play a bigger role because they are not under shareholder pressure to develop revenue-generating drugs.
Some experts say governments need to step up their efforts and offer more financial incentives to businesses. These US government efforts have led to increased development – 42 antibiotics were in development in March 2019, up from 6 in 2004 – but many drugs have been redundant or have not responded to some of the most urgent threats, according to Pew charitable trusts.
"Tuberculosis is much narrower and focused and sets a precedent in the world of nonprofit organizations," said Helen Boucher, a professor of medicine at Tufts Medical Center and director of the Tufts Center for Integrated Management of Antimicrobial Resistance.
"Economists have told us and others that a non-profit model would not be enough to meet the needs of the strong, renewable pipeline we need in America."
The nonprofit model is promising for neglected diseases and those that mainly affect residents of the poorest countries, Boucher said.
"There is no market for sale [a TB drug] to make money, so it was imperative that a nonprofit organization support it, Boucher said. Any progress is a positive progress. "
2019 © The Washington Post
This article was originally published by The Washington Post.