FDA Antimicrobial Drugs Advisory Committee votes in favour of Solitaire (solithromycin) in community-acquired bacterial pneumonia- Cempra

Cempra has announced that the majority of the U.S. FDA Antimicrobial Drugs Advisory Committee (AMDAC) voted (7-6) that efficacy results of Cempra�s Solitaire (solithromycin) outweigh the risks for the treatment of community-acquired bacterial pneumonia (CABP). Members of AMDAC voted unanimously (13-0) that there was substantial evidence of the efficacy of solithromycin for CABP. The committee also voted (12-1) that the risk of hepatotoxicity with solithromycin had not been adequately characterized and discussed a variety of potential approaches to further characterize the existing liver safety information on solithromycin.

Comment: The target date for the FDA to take action under the Prescription Drug User Fee Act (PDUFA) is December 27 and 28, 2016 for the oral and IV filings, respectively. The aim is to make solithromycin available to patients for a five to seven day course of an oral and/or IV macrolide as monotherapy for CABP.