FDA Accepts New Drug Application for Bacterial Pneumonia Treatment

The FDA recently accepted Cempra, Inc’s New Drug Application (NDA) for Solithera (solithromycin) for the treatment of community-acquired bacterial pneumonia (CABP).

Solithromycin was found to be 8 to 16 times more potent than azrithromycin against resistant bacteria. The FDA accepted the application for both the oral capsules and the intravenous version, according to a press release from Cempra.

The approval was based on positive topline results for a pair of phase 3 studies. The first was a clinical trial of the oral capsules. The second study was a clinical trial of intravenous solithromycin to oral solithromycin.

In both preclinical and clinical trials, researchers found that solithromycin was able to show activity against S. pneumoniae, community-acquired methicillin resistant S. aureus, streptococci, haemophilus, enterococci, Mycobacterium avium, and against other atypical bacteria.

"The FDA's acceptance of our 2 NDA filings brings us one step closer to the potential approval by the end of 2016 and US commercial launch of Solithera," said Prabhavathi Fernandes, PhD, president and chief executive officer of Cempra. "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."