Solithera narrowly wins panel's risk/benefit vote

FDA's Antimicrobial Drugs Advisory Committee voted 7-6 that the efficacy of oral and IV Solithera solithromycin from Cempra Inc. (NASDAQ:CEMP) outweighs their hepatotoxicity risk in the treatment of community acquired pneumonia (CABP).

The committee also voted 13-0 that Cempra demonstrated efficacy for the fluoroketolide/macrolide antibiotic, but 12-1 that the candidate's hepatotoxicity risk had not been adequately characterized...