FDA approves tuberculosis drug that works on hard-to-treat cases

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U.S. regulators have approved a new tuberculosis medication that shortens and improves treatment for the hardest-to-treat cases — a worsening problem in many poor countries.

It’s the first TB drug developed by a nonprofit group, the TB Alliance , which was formed to come up with better treatments. It has been developing this drug since 2002.

The Food and Drug Administration approved pretomanid for use with two other drugs for TB, a bacterial infection that attacks the lungs . In a clinical trial that enrolled 109 patients in South Africa, the three-pill combo cured about 90% of patients with very drug-resistant TB, usually within six months. More than 10% of patients experienced side effects, including nausea, vomiting, anemia and and a type of nerve damage called peripheral neuropathy .

The drug regimen also appears to stop patients spreading the deadly bacterial infection after a few days’ treatment.

Advertisement Until now, the best option cured about two-thirds of patients and took 18 to 30 months, according to the TB Alliance.

“Amazingly, it’s the first time that a treatment for XDR-TB infections has been recognized for actually working — no other treatment has demonstrated any consistent effectiveness,” Jamie Bay Nishi, director of the Global Health Technologies Coalition , said in a statement.

More than 123 countries have reported cases of the most drug-resistant strains of TB, according to the World Health Organization. They are rare in the U.S., but when they come up, the cost of treating a single patient can be as high as $513,000, according to the Centers for Disease Control and Prevention.

The TB Alliance said pretomanid should be available in the United States by the end of the year. The nonprofit group is also seeking approval from European regulators.

Advertisement The Associated Press contributed to this report.