Bayer Announces Orphan Drug Designation Of Ciprofloxacin DPI For NCFB

Bayer HealthCare announced that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development has designated orphan drug status to its investigational ciprofloxacin DPI (dry powder for inhalation) for the treatment of non-cystic fibrosis bronchiectasis (NCFB).

Ciprofloxacin DPI is currently under development by Bayer as chronic intermittent therapy to reduce the frequency of acute exacerbations in NCFB patients with bacterial respiratory pathogens. The drug aims to arrest the vicious cycle suffered by those with NCFB who experience frequent severe acute pulmonary bacterial exacerbations which lead to further inflammation as well as airway and lung parenchyma damage. The investigational treatment contains the active ingredient ciprofloxacin. Ciprofloxacin is a fluoroquinolone antibiotic formulated into dry powder for inhalation via Novartis’ PulmoSphere technology. The drug is administered using the T-326 Dry Powder inhaler.

Non-cystic fibrosis bronchiectasis (NCFB) is a chronic respiratory disease, of which up to 50 to 80 percent may be idiopathic. Recurrent microbial infection and inflammation causes further damage of the airway walls which, in turn, makes the lung vulnerable to new infections. Bacterial colonization of the airways is found in over 60 percent of adult patients with stable bronchiectatic disease. Presence of Pseudomonas aeruginosa bacteria in particular has been associated with the accelerated decline of lung function in affected patients.

Orphan drug designation is awarded to drugs and biologics intended for safe and effective treatment, diagnosis, or prophylaxis of rare diseases and disorders. To be awarded an orphan drug status, the drug candidate must be intended to treat a disease affecting no more than 200,000 people in the U.S. or a disease that affects more than 200,000 but is not expected to recover the expenses of drug development and commercialization.

The investigational treatment ciprofloxacin DPI is being evaluated in the global Phase III clinical trial program RESPIRE.