Cempra To Defend CABP Antibiotic's Safety At US FDA Advisory Panel
Solithera's efficacy profile appears strong, but FDA has safety concerns, particularly its structural similarities to the controversial Ketek.
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Limited population approval pathway in 21st Century Cures law may not help Cempra overcome US agency's request for new 9,000-patient safety study of the macrolide antibiotic.
Panelists recommended stringent labeling for Cempra's proposed antibiotic for community-acquired bacterial pneumonia, which could ultimately limit utilization of the drug over concerns about possible liver damage.
FDA advisory committee votes 7-6 that the strong efficacy profile of Solithera (solithromycin) outweighs its unknown safety risks; panels agreed that more data was needed, but were split on whether it was needed pre- or post-approval.