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New antibiotic approved for drug resistant tuberculosis

(Jacquelyn Martin / AP)

On Wednesday, the Food and Drug Administration approved a new drug for highly drug resistant tuberculosis, the world's leading infectious cause of death.

Tuberculosis kills 1.6 million people a year, about 500,000 of whom suffer from drug-resistant strains of the disease.

The antibiotic, called pretomanid, was developed by a nonprofit group called the TB Alliance at a time when few companies are investing in the expensive and unprofitable endeavor to create the next generation of antibiotics.

Some researchers hope that the TB Alliance can serve as a model for antibiotic therapy when health authorities warn of the growing danger of drug-resistant infections. The UN has predicted that such infections could cause 10 million deaths each year until 2050 if nothing is done.

"We can have a huge impact on the lives of people who are affected and also take a big step toward ultimately eradicating, eradicating a disease like tuberculosis," says Mel Spigelman, president and CEO of TB Alliance.

Pharmaceutical companies have largely abandoned the development of antibiotics because they can cost up to $ 1 billion to market but produce much less revenue than chronic conditions drugs, such as high blood pressure and high cholesterol, or specialty drugs that can cost hundreds of thousands of dollars or more. Antibiotics are often inexpensive and are taken for days or weeks at a time compared to anti-cancer drugs and chronic illnesses taken over months or years.

All antibiotics approved in the last decade have disappointed sales, and Achaogen, a company that had approved an antibiotic last year, filed for bankruptcy in April.

Pretomanide is part of a three-drug regimen against highly resistant forms of TB and is the third FDA-approved anti-TB drug in more than 40 years. The TB Alliance said that 95 of the first 107 patients in its clinical trial had a successful outcome after six months of treatment with the three-drug regimen. The historical success rate for treatment is 34 percent.

Drug resistant TB is currently being treated with countless drugs and may require thousands of pills. According to the World Health Organization, it has been reported by more than 120 countries.

Bacterial infections develop resistance to antibiotics used against them, which means that once treatable infections, including certain forms of tuberculosis, have become extra difficult to treat. Experts have warned of a threatening post-antibiotic era, where many infections can become untreatable.

TB Alliance said it hopes the FDA's approval will allow other countries, such as China, India and South Africa, to okay the drug and make it available to its residents. The disease is very contagious and spreads through coughing, sneezing or even talking.

In the New England Journal of Medicine this month, researchers and doctors for infectious diseases argued that the current model of antibiotic development is broken, especially as the few companies that do develop them ultimately compete with each other to develop drugs for the same infections. Instead, the nonprofits, including the TB Alliance, propose to take on a bigger role as they do not face pressure from shareholders to develop revenue-generating drugs.

Some experts say that governments must increase and offer more financial incentives for businesses. Such efforts by the US government have led to an increase in development – 42 antibiotics were under development in March 2019, compared to six in 2004 – but many of the drugs have been redundant or have not addressed some of the most urgent threats, according to Pew Charitable Trusts .

"TB is much narrower and more focused and has a precedent in the non-profit world," said Helen Boucher, professor of medicine at Tufts Medical Center and head of the Tufts Center for Integrated Management of Antimicrobial Resistance. "Economists have told us and others that a nonprofit model would not be enough to meet the needs of the robust and renewable pipeline we need in America."

The nonprofit model promises for neglected diseases and those that primarily affect residents of poorer countries, Boucher said.

"There is no market to sell [a TB drug] to make money so it was imperative that a nonprofit take it further," Boucher said. "All progress is good progress."

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