FDA Advisory Committee Narrowly Backs Cempra' Solithromycin For CAPD

(RTTNews) - Cempra, Inc. (CEMP) announced that the U.S. Food and Drug Administration' Antimicrobial Drugs Advisory Committee voted 7-6 that efficacy results of its solithromycin outweigh the risks for the treatment of community-acquired bacterial pneumonia.

The company noted that 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.

Prabhavathi Fernandes, president and chief executive officer of Cempra, said, "We appreciate the meaningful discussion from today's panel. 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,"

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.