Posted by Michael Wonder on 14 Aug 2019
FDA approves new drug for treatment-resistant forms of tuberculosis that affects the lungs
14 August 2019 - Approval marks the second drug approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs and signals FDA’s continued focus on facilitating development of new treatments to fight antimicrobial resistant infections.
The U.S. Food and Drug Administration today approved pretomanid tablets in combination with bedaquiline and linezolid for the treatment of a specific type of highly treatment-resistant tuberculosis of the lungs.
The safety and effectiveness of pretomanid, taken orally in combination with bedaquiline and linezolid, was primarily demonstrated in a study of 109 patients with extensively drug-resistant, treatment intolerant or non-responsive multidrug-resistant pulmonary tuberculosis.
