The FDA Antimicrobial Drugs Advisory Committee (AMDAC) has voted 7-6 that the efficacy results of Cempra’s solithromycin outweigh the risks for the treatment of community-acquired bacterial pneumonia (CABP). The members of the AMDAC also voted unanimously that there was substantial evidence of the efficacy of solithromycin for CABP.
However, in a 12-1 vote, the committee determined that the risk of hepatotoxicity with solithromycin had not been characterized. For this reason, members discussed a wide variety of potential approaches to further characterize the existing liver safety information on the product.
"We appreciate the meaningful discussion from today's panel,” Prabhavathi Fernandes PhD, president and chief executive officer of Cempra, said in a press release. “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 5- to 7-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 is December 27 and 28 of this year for oral and IV filings, respectively.
Solithromycin, a macrolide, has shown potent activity against S. pneumoniae in in vitro and in vivo studies. It has also shown an extended spectrum of activity against community-acquired methicillin resistant S. aureus, streptococci,Haemophilus, enterococci, and Mycobacterium avium, and in animal models of malaria.