Cempra Says FDA Accepts Solithera NDA Community-Acquired Bacterial Pneumonia Treatment

Cempra, Inc. CEMP said that its New Drug Applications (NDAs) for SolitheraTM (solithromycin) approval as a treatment for community-acquired bacterial pneumonia (CABP) were accepted for filing by the Food and Drug Administration.

Cempra said the acceptance of two NDAs, one for the intravenous formulations while the other for oral capsules, indicated that the applications were sufficiently complete to permit a substantive review by the FDA.

The company's president and CEO, Prabhavathi Fernandes, stated, "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. 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."

Cempra said the NDA submissions were supported by safety, as well as efficacy data from two final stage trials of solithromycin in the treatment of CABP. The first trial was a pivotal Phase 3 clinical trial of solithromycin oral capsules, and the second was a global, pivotal final stage clinical study of intravenous solithromycin progressing to oral solithromycin. In 2015, positive topline results were disclosed for both the final stage studies.

In the pre-market trading on Tuesday, the stock traded 0.5 percent down.