The U.S. FDA has accepted two new drug applications (NDAs) from Cempra, which develops antibiotics for bacterial infectious diseases, for Solithera (solithromycin) as a treatment for community-acquired bacterial pneumonia (CABP).
The FDA’s acceptance of the applications for Solithera’s oral capsules and the intravenous formulation of the compound indicates the applications were considered to be sufficiently robust to allow for a review by the federal agency.
“The FDA’s acceptance of our two NDA filings brings us one step closer to the potential approval by the end of 2016 and U.S. commercial launch of Solithera,” said Dr. Prabhavathi Fernandes, Cempra’s president and CEO, in a press release.
“If approved, Solithera would be a significant milestone in the treatment of CABP, as bacterial resistance to older treatments has continued to rise. The FDA will convene a meeting of the Antimicrobial Drugs Advisory Committee for Solithera prior to its action on the applications,” Fernandes added.
Solithromycin is the first highly potent next-generation macrolide and fluoroketolide strong enough to fight most macrolide-resistant strains. Studies including in vivo and in vitro tests have shown solithromycin to be potent against S. pneumoniae, as well as against community-acquired methicillin resistant S. aureus (CA-MRSA), streptococci and hemophilius, among others.
The supporting NDA submission studies included two Phase 3 clinical trials. The first study was a pivotal Phase 3 clinical trial of solithromycin oral capsules and the second was a global, pivotal Phase 3 clinical trial of intravenous solithromycin progressing to oral solithromycin. Positive topline results were announced for both clinical trials.
Solithromycin is active against resistant strains because of its ability to interact with three sites on the bacterial ribosome, in opposition to current macrolides that only interact with one. This mechanism of action should limit the development of bacterial resistance to solithromycin.
CAB pneumonia is one of the most commonly diagnosed bacterial infections in the U.S. Microbial resistance is becoming a threat, in addition to concerns over antibiotic tolerability and its impact on intestinal microflora, and it is becoming increasingly urgent to find innovative treatments for CABP. Antibiotic resistance is a complex, emerging global concern with potentially devastating impacts on public health.