The Food and Drug Administration (FDA)’s Antimicrobial Drugs Advisory Committee (AMDAC) voted 7-6 that the benefits of solithromycin outweigh the risks associated with this treatment for community-acquired bacterial pneumonia (CABP).
The AMDAC voted 13-0 that substantial evidence on the efficacy of solithromycin existed for CABP. The Committee also voted 12-1 that the risks of hepatotoxicity with solithromycin were not adequately characterized and discussed potential approaches to further characterize the existing data on solithromycin.
Solithromycin, a highly potent macrolide, has shown activity against S. penumoniae as well as a broad spectrum of activity against community-acquired S. aureus, streptococci, haemophilus, enterococci, Mycobacterium avium and in animal models of malaria. In addition, it has shown activity against atypical bacteria (eg, legionella, chlamydia, mycoplasma ureaplasma), gonococci, and other organisms that cause genitourinary tract infections.
Solithromycin is 8-16 times more potent than azithromycin against many bacteria and is active against azithromycin-resistant strains. Its activity against resistant strains is due to its ability to interact with three sites on the bacterial ribosome vs. a single binding site of 1st- and 2nd-generation macrolides.
The target action date for the FDA under the Prescription Drug User Fee Act (PDUFA) is December 27 for the oral formulation and December 28 for the IV formulation. Solithromycin would be the first new macrolide antibiotic with an oral and IV formulation approved in over two decades.
For more information call (919) 313-6601 or visit Cempra.com.