FDA Defends ‘Paradoxical’ Approval Of J&J’s TB Drug Sirturo In NEJM
This article was originally published in The Pink Sheet Daily
Executive Summary
Imbalance of deaths for bedaquiline patients despite efficacy on surrogate marker in Phase II study supporting accelerated approval is still unexplained with longer-term data. But with efficacy also still looking good, FDA defends approval for select population with high unmet need.