Cempra Inc. announced it has completed submissions to the U.S. Food and Drug Administration (FDA) of a New Drug Application (NDA) for its lead product candidate solithromycin for the treatment of community-acquired bacterial pneumonia (CABP).
Based on previous FDA designation of Qualified Infectious Disease Product (QIDP) to solithromycin, Compra has FDA Priority Review, and has been granted Fast Track program, and a five-year extension of exclusivity under the Hatch-Waxman Act.
Cempra has Priority Review, and has been granted Fast Track for both the intravenous and oral capsule formulations for the treatment of CABP. Also, based on the Prescription Drug User Fee Act (PDUFA) performance goals, the FDA decision on the NDA for solithromycin is expected within eight months.
“Completion of the rolling submission of our first NDAs during Cempra’s 10-year anniversary year represents a major milestone for the company and a significant step toward our goal of developing antibiotics to meet the critical medical needs of patients in the treatment of bacterial infectious diseases,” said Prabhavathi Fernandes, Ph.D., president and CEO of Cempra, in a recent press release. “We believe the intravenous and capsule formulations will provide dosing flexibility that could lead to fewer hospital admissions, earlier discharge if admitted, and increased treatment of CABP on an outpatient basis. We are confident we have a strong data package for solithromycin.”
“The management of CABP remains a challenge to healthcare professionals and I firmly believe that solithromycin has the potential to be a significant part of the treatment of this life-threatening illness, given its published clinical efficacy and potential for multiple formulations,” said Thomas M. File, M.D., principal investigator for solithromycin clinical trials, Northeast Ohio Medical University. “Solithromycin’s potency, spectrum of activity, and tolerability could help to offset the rising problem of bacterial resistance, and it is gratifying to note that patients could be closer to benefiting from this potential new treatment.”
The FDA has a review period of 60 days to decide if NDAs are satisfactory for filing, and to confirm if Priority Review has been granted. Cempra’s submissions in the European Union are expected to be completed next month.