Advisory Committee Recommendations Could Limit Use Of Solithera
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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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.
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.
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.