FDA panel narrowly supports benefit, risk profile of Cempra's solithromycin

Cempra announced that an FDA advisory committee voted 7-6 that efficacy results for the company's experimental antibiotic solithromycin outweigh the risks for the treatment of community-acquired bacterial pneumonia (CABP). The drugmaker noted that the agency's target review dates for filings seeking approval of oral and intravenous (IV) formulations of solithromycin are December 27 and 28, respectively.

According to Cempra, the Antimicrobial Drugs Advisory Committee voted unanimously that there was substantial evidence of the efficacy of solithromycin. Ahead of the vote, FDA staff said that the drug can cause an elevation in liver enzyme levels, noting that "a significant safety signal for hepatotoxicity was observed in the solithromycin development programme." The company indicated that the advisory committee voted 12-1 that the risk of hepatotoxicity associated with the drug had not been adequately characterised.

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"We appreciate the meaningful discussion from [the] panel," commented Cempra CEO Prabhavathi Fernandes, adding "their supportive view and thoughtful comments on approaches to ensuring appropriate use are consistent with Cempra's commitment to make solithromycin available to the right patients for a five to seven day course of an oral and/or IV macrolide as monotherapy for CABP."

For related analysis, see ViewPoints: Shadow of Ketek looms large over FDA’s review of Cempra’s Solithera.

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