The U.S. Food and Drug Administration today approved drug treatment for resistant tuberculosis (TB) of the lungs.
The FDA approved Pretomanid Tablets in combination with bedaquiline and linezolid for the treatment of a specific type of tuberculosis of the lungs, specifically drug-resistant, treatment-intolerant, or nonresponsive multidrug-resistant pulmonary TB. These forms of TB are difficult to treat due to resistance to available therapies.
“The threat of antimicrobial-resistant infections is a key challenge we face as a public health agency,” FDA Principal Deputy Commissioner Amy Abernethy said. “The bacterium that causes tuberculosis can develop resistance to the antibiotics used to treat it.”
According to the World Health Organization, in 2016, there were an estimated 490,000 new cases of multidrug-resistant TB worldwide, with a smaller portion of cases of extensively drug-resistant TB. These forms of TB are a public health threat due to limited treatment options, so new treatments are essential to meet patient needs, Abernathy said.
“That’s why, among our other efforts to address antimicrobial resistance, we’re focused on facilitating the development of safe and effective new treatments to give patients more options to fight life-threatening infections,” Abernathy said.
This approval is the second time a drug has been approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs. The pathway was advanced by Congress to spur the development of drugs targeting infections that lack effective therapies.
“We hope we continue to see more development of antibacterial drugs for treating serious or life-threatening infections in limited populations of patients with unmet medical needs,” Abernathy said.
The safety and effectiveness of Pretomanid, taken orally in combination with bedaquiline and linezolid, was demonstrated on tests of 109 patients.
The FDA approved Pretomanid Tablets to The Global Alliance for TB Drug Development.