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FDA Approves New TB Drug Pretomanid

Pretomanid is an antibiotic that belongs to the class of drugs called nitroimidazole.


The U.S. Food and Drug Administration (FDA) approved a new tuberculosis (TB) medication that can shorten and improve treatment in people with severe and tough-to-treat TB.

A nonprofit group called “TB Alliance” has developed a drug called pretomanid by using fund from government agencies and charities.

On Wednesday, the FDA approved the use of pretomanid along with two other antibiotics.

Years of incomplete and ineffective treatment has been resulting in TB strains that have become drug-resistant, meaning they are not killed by standard medications anymore.

According to a new study, a combination pretomanid, linezolid (Zyvox) and bedaquiline (Sirturo) cured more than 90 percent of patients who had multidrug-resistant TB within six months. Also, patients with a history of HIV who contracted TB fared well with the combination of these drugs.

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Researchers found that pretomanid prevented the spread of the bacterial infection within a few days of treatment.

TB Alliance CEO Mel Spigelman said, “Until now, the best option cured about two-thirds of patients, took 18 to 30 months and required up to eight kinds of shots and pills. Many patients die or don’t finish treatment.”

TB kills more than 1.6 million people every year worldwide.

Potential side effects of this combinational therapy include nerve pain, liver damage, and irregular heartbeats.

According to Spigelman, the new combo could help more than 75,000 patients every year, mostly in China, Indonesia, India, South Africa, and Nigeria.

Although there are not many severe TB cases in the United States, the FDA is the first drug regulatory body to approve pretomanid in association with Zyvox and Sirturo. However, this FDA’s nod would bring instant approval in nations where TB is endemic. TB alliance will team up with the World Health Organization (WHO) to get quick approval of the treatment in those nations. The nonprofit organization will be working with several generic manufacturers to make pretomanid available and affordable.