The Food and Drug Administration on Wednesday approved a new drug for the highly drug resistant tuberculosis, the leading infectious cause of death in the world.
Tuberculosis kills 1.6 million people a year, about 500,000 of whom suffer from drug-resistant strains of the disease.
An antibiotic called pretomanide was developed by a non-profit group called TB Alliance at a time when few companies are investing in the expensive and unprofitable venture to create the next generation of antibiotics.
Some researchers hope that the TB Alliance can serve as a model for the development of antibiotic drugs, as health authorities warn of the increasing risk of drug-resistant infections. The United Nations estimates that such infections could lead to 10 million deaths each year by 2050 if nothing is done.
"We can have a huge impact on the lives of those affected, and we can also take a big step in the end, really, of eradicating a disease like tuberculosis," says Mel Spiegelman, President and CEO of TB Alliance
Drug companies have largely abandoned the development of antibiotics, as they can cost over $ 1 billion to bring to the market, but produce far less revenue than chronic drugs, such as high blood pressure and you ok cholesterol, or specialized drugs that can cost hundreds of thousands of dollars or more Antibiotics are often inexpensive and taken for days or weeks compared to cancer and chronic drugs taken for months or years.
All antibiotics approved in the last decade have had disappointing sales, and Achaogen, a
Pretomanid is part of a regimen of three drugs for highly resistant forms of tuberculosis and is the third FDA-approved anti-tuberculosis drug for more than 40 hours . TB Alliance said 95 of its first 107 patients in the clinical trial had a successful outcome after six months of treatment with three medicines. The treatment success rate is 34 percent.
Tuberculosis-resistant tuberculosis is currently treated with innumerable drugs and may require thousands of pills. According to the World Health Organization, more than 120 countries have reported.
Bacterial infections develop antibiotic resistance against them, which means that once treatable infections, including some forms of tuberculosis, become extremely difficult to treat. Experts have warned of the coming era after antibiotics, in which many infections can become incurable.
The TB Alliance stated that it hoped the FDA's approval would allow other countries such as China, India and South Africa to remedy the drug and make it available to their residents. The disease is highly contagious and is spread by coughing, sneezing or even speaking.
This month in the New England Journal of Medicine, researchers and practitioners of infectious diseases claim that the current model for the development of antibiotics has been disrupted, especially as the few companies that develop them eventually compete with each other to develop drugs for the same infections. Instead, they propose nonprofit organizations, including TB Alliance, to play a greater role, as they do not face pressure from shareholders to develop revenue-generating drugs.
Some experts say governments need to step up and offer more financial incentives to companies. Similar efforts by the US government have led to an increase in development – 42 antibiotics were under development in March 2019, compared with six in 2004, but many drugs were unnecessary or did not address some of the most pressing threats , according to Pew Charitable Trusts.
"Tuberculosis is much narrower and more focused and has a precedent in the nonprofit world," says Helen Boucher, professor of medicine at Tufts Medical Center and director of the Center for Integrated Tufts Antimicrobial Resistance Management. "Economists have told us others that the non-profit model would not be adequate to meet the needs of the healthy and renewable pipeline we need in America."
The non-profit model is promising for neglected diseases and those, which mainly affect residents in the poorer
"There is no market to sell [a TB drug] to make money, so it is imperative for a non-profit to take that," Bucher said. "All Progress Is Good Progress."