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Advisory Committee Recommendations Could Limit Use Of Solithera

Executive Summary

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.

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Cempra Gets Easier Path To CRL Response, But Who Will Fund The Study?

The biotech now only needs to investigate liver toxicity in 6,000 patients – down from 9,000 – to refile its NDA, but Cempra made clear that it won't initiate the study without an external funding source.

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Even if Cempra has the funds to conduct another trial, there is no guarantee for approval; if approved, solithromycin’s labeling would likely limit use of the community-acquired pneumonia antibiotic.

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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.

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