FDA Panel Narrowly Recommends Approval of Cempra’s Pneumonia Antibiotic

An FDA advisory committee has narrowly backed the approval of Cempra’s antibiotic Solithera for the treatment of community-acquired bacterial pneumonia, despite raising concerns about the candidate’s safety profile and study sample size.

The committee members voted 7-6 on whether the benefits of Cempra outweigh the risks, with all the panelists acknowledging the candidate’s efficacy, but splitting on whether additional studies should be conducted on drug-induced liver injuries before or after an approval.

If given an approval, Cempra should plan to engage in post-marketing surveillance studies to determine the whether the liver injury signal noted by FDA staff could pose a legitimate risk to patients, the panel said.