WHIPPANY, N.J. — Bayer HealthCare on Tuesday announced that the Food and Drug Administration's Office of Orphan Products Development has granted orphan drug designation for Bayer's investigational Ciprofloxacin Dry Powder for Inhalation (Ciprofloxacin DPI) for the treatment of non-cystic fibrosis bronchiectasis. Patients with NCFB suffer from frequent severe acute pulmonary bacterial exacerbations, which lead to further inflammation, airway and lung parenchyma damage.
The Orphan Drug Designation program provides orphan status to drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases and disorders that affect fewer than 200,000 people in the United States, or that affect more than 200,000 but are not expected to recover the costs of developing and marketing a treatment drug.
Ciprofloxacin DPI is in development by Bayer HealthCare as chronic intermittent therapy for reducing the frequency of acute exacerbations in NCFB patients with bacterial respiratory pathogens. It comprises ciprofloxacin, a fluoroquinolone antibiotic, formulated into dry powder for inhalation using Novartis' PulmoSphere technology and is administered with the T-326 Dry Powder inhaler. Ciprofloxacin DPI therapy in NCFB currently is being investigated in a global Phase III clinical trial program.