The Food and Drug Administration on Wednesday approved a new anti-drug drug tuberculosis, the leading infectious cause of death. annually, about 500,000 of them suffer from drug-resistant diseases.
The antibiotic, called pretomanid, was developed by a nonprofit group called the TB Alliance at a time when several companies were investing in expensive and unprofitable efforts to create next-generation antibiotics.
Some researchers hope that the TB Alliance may serve as a model for the development of antibiotic drugs as health authorities warn of the increased risk of drug-resistant infections. The United Nations estimates that such infections can cause 10 million deaths every year by 2050 if nothing is done. "
" We can have a significant impact on the lives of people who suffer and also take a major step in eventually eradicating a disease such as TB, "said Mel Spigelman, president and chief executive officer of TB Alliance. "One definite advantage of a not-for-profit is that you don't have to look at things like returning your profits to shareholders."
Drug companies have largely abandoned development of antibiotics because they can cost upwards of $ 1 billion to bring to market but produce less revenue than drugs for chronic conditions, such as high blood pressure and high cholesterol, or special Medicines that can harvest hundreds of thousands of dollars or more in revenue per dose Antibiotics are often inexpensive and take days or weeks at a time, compared to drugs for cancer and chronic disease. a took months or years.
All antibiotics approved in the last decade have had sales failures, and Achaogen, a company that had an antibiotic approved last year, filed for bankruptcy in April.
Pretomanid is part of a three-drug regimen against highly resistant forms of TB and is the third FDA-approved drug for over 40 years. The TB Alliance said 95 of its first 107 patients in this clinical trial had a successful outcome after six months of treatment with the three-drug regimen. The historical success rate in treatment is 34 percent.
TB intoxicating drugs is currently being treated with many drugs and may require thousands of pills. It is reported in more than 120 countries, according to the World Health Organization.
Bacterial infections develop resistance to the antibiotics used against them, which means that once cured infections, including some forms of tuberculosis, become extremely difficult to treat. Experts warn of a strong post-antibiotic era, where many infections can be irreversible.
The TB Alliance says that the FDA's approval is hoping to enable other countries, such as China, India and South Africa to make the drug okay and make it available to their residents. The disease is highly contagious and spreads through coughing, sneezing or even talking.
In this month's New England Journal of Medicine, researchers and infectious disease doctors argue the current model for antibiotic development is broken, especially since some companies that make it end up compete with each other to develop drugs for the same infections. Instead, they suggest that nonprofit organizations, including the TB Alliance, take a bigger role because they do not face pressure from shareholders to develop revenue-generating drugs. 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 redundant or failed to address some of the most – immediate threat, according to The Pew Charitable Trusts.
"TB is narrower and more focused and has the world's foremost non-profit," said Helen Boucher, a professor of medicine at Tufts Medical Center and director of the Tufts Center for Integration. Antimicrobial Resistance Management. "Economists and others have told us that a poor model is not enough to meet the demands for the stable and transformable pipeline we will need in America."
The undeveloped model promises for neglected diseases and the major impacts on residents in poorer countries, Boucher said.
"There is no market to sell [a TB drug] to make money so it's not necessary that a non-profit take it," Boucher said. "Any development is good development."