US FDA reviewers: Janssen's MDR-TB drug bedaquiline safe, effective
This article was originally published in Scrip
Executive Summary
Janssen's experimental oral medicine bedaquiline 100mg is more effective than placebo in treating multi-drug resistance in Mycobacterium tuberculosis (MDR-TB) based on a surrogate endpoint of sputum culture conversion (SCC), with trial data showing the drug is safe and well-tolerated, although US FDA drug reviewers raised some concern about an increase in QTcF with the 400mg dosage.