The FDA has given the greenlight for non-profit group TB Alliance’s Pretomanid tablets, in combination with bedaquiline and linezolid, for a form of highly treatment-resistant tuberculosis.
Pretomanid is now approved to treat adult patients with extensively drug resistant, treatment-intolerant or nonresponsive multidrug resistant pulmonary TB, a form of the disease that is hard to treat due to its resistance to existing therapies.
Pretomanid is a nitroimidazole — a class of novel anti-bacterial agents. It is the second drug approved under the FDA’s limited population pathway for antibacterials and antifungals, an approval route designed to speed drug development for infections that lack effective therapies.
“Multidrug-resistant TB and extensively drug-resistant TB are public health threats due to limited treatment options,” said FDA Principal Deputy Commissioner Amy Abernethy. “That’s why, among our other efforts to address antimicrobial resistance, we’re focused on facilitating the development of safe and effective new treatments.”