Bayer's Ciprofloxacin DPI receives FDA orphan drug designation for NCFB treatment
Published on April 23, 2014 at 12:39 AM
Bayer HealthCare today announced that the U.S. Food and Drug Administration's (FDA) Office of Orphan Products Development has granted orphan drug designation for its investigational Ciprofloxacin Dry Powder for Inhalation (Ciprofloxacin DPI) for the treatment of non-cystic fibrosis bronchiectasis (NCFB). 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 U.S, or that affect more than 200,000 but are not expected to recover the costs of developing and marketing a treatment drug.