Cempra, Inc. announced that the majority of the U.S. Food and Drug Administration (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) voted (7-6) that efficacy results of Cempra's 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.
"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," said Prabhavathi Fernandes Ph.D., president and chief executive officer of Cempra.
"Antibiotic resistance is reaching alarming rates across the globe. In the U.S. alone, pneumonia is the leading cause of death due to infectious disease and rates of pneumococcal resistance to current macrolides for the treatment of CABP can exceed 50 percenti. We believe solithromycin has the potential to offer patients and physicians an important new treatment option and we look forward to continuing to work with the FDA as it completes its review," Fernandes added.
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 FDA is not bound by the Advisory Committee's guidance, but takes its advice into consideration when reviewing investigational medicines. If approved, solithromycin would be the first new macrolide antibiotic with an oral and IV formulation in over 20 years
