Bayer Secures FDA Orphan Drug Designation for Investigational Ciprofloxacin DPI
Bayer HealthCare 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).
According to a release, patients with NCFB suffer from frequent severe acute pulmonary bacterial exacerbations which lead to further inflammation, airway and lung parenchyma damage.
The Company noted that 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.
Bayer HealthCare added that 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).
NCFB is a chronic respiratory disease of which up to 50 to 80 percent of cases may be idiopathic. A vicious cycle of recurrent microbial infections and persistent inflammation leads to further damage of airway walls and predisposes the lung to new infections.2,3 Bacterial colonization of the airways, most commonly with Haemophilus influenzae and Pseudomonas aeruginosa, is found in more than 60 percent of adult patients with stable bronchiectatic disease. In particular, presence of Pseudomonas aeruginosa has been associated with accelerated decline in lung function.
Bayer HealthCare Pharmaceuticals is a pharmaceuticals business of Bayer HealthCare.
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