FDA Grants Bayer HealthCare Pharmaceuticals Orphan Drug Designation for Cystic Fibrosis Treatment
Bayer HealthCare Pharmaceuticals announced today that an orphan drug designation has been granted by the U.S. Food and Drug Administration (FDA) for ciprofloxacin dry powder inhaler (DPI) for management of pulmonary infection due to Pseudomonas aeruginosa in cystic fibrosis (CF) patients. A similar designation has already been granted by the European Medicines Agency.
Ciprofloxacin DPI is an investigational drug-device combination that combines ciprofloxacin dry powder formulated using Novartis' Proprietary PulmoSphere technology with a delivery inhaler. Ciprofloxacin DPI is in Phase II development and is being studied for its safety and potential to improve lung function, as measured by the forced expiratory volume in 1 second (FEV1), in patients with CF.
"There continue to be significant unmet medical needs for people with cystic fibrosis," said Shannon Campbell, Vice President and General Manager, Oncology and General Medicine, Bayer HealthCare Pharmaceuticals. "We are pleased to receive the orphan drug designation from the FDA for ciprofloxacin DPI, which we are researching as a potential treatment option for management of pulmonary infections due to P. aeruginosa in CF patients."