FDA Approves New Option for Drug-Resistant Pulmonary TB

Pretomanid tablets in combination with bedaquiline and linezolid has been approved by the US Food and Drug Administration to treat a limited and specific population of adult patients with extensively drug-resistant, treatment-intolerant, or nonresponsive multidrug-resistant pulmonary tuberculosis.

“The threat of antimicrobial-resistant infections is a key challenge we face as a public health agency,” said FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD. “The bacterium that causes tuberculosis can develop resistance to the antibiotics used to treat it. Multidrug-resistant TB and extensively drug-resistant TB are public health threats due to limited treatment options. New treatments are important to meet patient national and global health needs.”

The safety and efficacy of this regimen was examined in a study of 109 patients with extensively drug-resistant, treatment-intolerant, or nonresponsive multidrug-resistant pulmonary tuberculosis. Six months after therapy ended, success was seen among 89% of participants.

The most common adverse reactions reported included peripheral neuropathy, acne, anemia, nausea, vomiting, headache, increased liver enzymes (transaminases and γ-glutamyltransferase), dyspepsia, rash, hyperamylasemia, visual impairment, hypoglycemia, and diarrhea.

—Amanda Balbi

Reference:

FDA approves new drug for treatment-resistant forms of tuberculosis that affects the lungs [press release]. Silver Spring, MD: US Food and Drug Administration; August 14, 2019. https://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-treatment-resistant-forms-tuberculosis-affects-lungs?utm_campaign=081419_PR_FDA%20approves%20new%20drug%20for%20treatment-resistant%20forms%20of%20tuberculosis.