FDA grants orphan status for Bayer's ciprofloxacin for cystic fibrosis

German drug major Bayer HealthCare has received an orphan drug designation from the US Food and Drug Administration 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 (EMEA), the company noted.

Ciprofloxacin DPI is an investigational drug-device combination that combines ciprofloxacin dry powder formulated using Swiss drugmaker 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, Bayer noted.

"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 at Bayer HealthCare Pharmaceuticals.