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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.






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