FDA Grants Orphan Drug Designation for Bayer ’ s Investigational Ciprofloxacin DPI (Dry Powder for Inhalation) for Treatment of Non-Cystic Fibrosis Bronchiectasis

WHIPPANY, N.J., April 22, 2014 /PRNewswire/ — 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. About Ciprofloxacin DPI 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 is currently being investigated in a global Phase III clinical trial program (RESPIRE; NCT01764841). About Non-Cystic Fibrosis Bronchiectasis NCFB is a chron...
Source: Cystic Fibrosis Worldwide Blog - Category: Respiratory Medicine Authors: Tags: Research and Discovery Source Type: blogs