Posted by Michael Wonder on 11 Mar 2019
TB medicine pretomanid enters regulatory review process in the United States
8 March 2019 - TB Alliance’s new drug application for the novel tuberculosis drug candidate pretomanid has been accepted for review by the United States FDA.
The application is for the use of pretomanid as part of a new regimen, in combination with bedaquiline and linezolid, for the treatment of extensively drug-resistant TB, treatment intolerant multidrug-resistant (MDR) TB, and treatment non-responsive MDR-TB.
The application for pretomanid has been granted priority review by FDA. The Prescription Drug User Fee Act action date for an FDA decision is in third quarter 2019.
