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Cempra, Inc., a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, announced that the U.S. Food and Drug Administration (FDA) has scheduled a meeting of the Antimicrobial Drugs Advisory Committee on November 4, 2016 in Silver Spring, Maryland to discuss the safety and efficacy of solithromycin to treat community-acquired bacterial pneumonia (CABP).
Cempra conducted two pivotal Phase 3 global registration trials of solithromycin. The first study was conducted with solithromycin oral capsules, and the second study tested intravenous (IV) solithromycin progressing to oral solithromycin. Both Phase 3 studies met their primary endpoints that were aligned with FDA guidance.
Solithromycin was granted qualified infectious diseases product (QIDP) designation which entitled the new drug applications (NDAs) to eight month priority reviews, resulting in PDUFA dates of December 27, and December 28, 2016, respectively, the oral and intravenous NDAs.
"Antimicrobial resistance is an urgent public health threat and we believe that the strong data we have seen with solithromycin in clinical trials supports its approval as a new IV and oral antibiotic that would meet an important unmet need in the treatment of both in-patient and out-patient CABP," said Prabhavathi Fernandes, Ph.D., president and chief executive officer of Cempra.
"We look forward to the November 4 discussion with the advisory committee, and continued dialogue with the FDA, as we progress towards the solithromycin PDUFA dates at the end of the year," Fernandes added.
