Bayer HealthCare Pharmaceuticals' ciprofloxacin DPI granted FDA orphan drug designation for CF treatment

Bayer HealthCare Pharmaceuticals announced today that an orphan drug designation has been granted by the U.S. Food and Drug Administration (FDA) for ciprofloxacin dry powder inhaler (DPI) for management of pulmonary infection due to Pseudomonas aeruginosa in cystic fibrosis (CF) patients. A similar designation has already been granted by the European Medicines Agency. Ciprofloxacin DPI is an investigational drug–device combination that combines ciprofloxacin dry powder formulated using Novartis' Proprietary PulmoSphere® technology with a delivery inhaler. Ciprofloxacin DPI is in Phase II development and is being studied for its safety and potential to improve lung function, as measured by the forced expiratory volume in 1 second (FEV1), in patients with CF.

"There continue to be significant unmet medical needs for people with cystic fibrosis," said Shannon Campbell, Vice President and General Manager, Oncology and General Medicine, Bayer HealthCare Pharmaceuticals.  "We are pleased to receive the orphan drug designation from the FDA for ciprofloxacin DPI, which we are researching as a potential treatment option for management of pulmonary infections due to P. aeruginosa in CF patients."

Cystic fibrosis is a life-threatening inherited disease affecting the lungs, pancreas, liver, and intestines. Approximately 30,000 patients in the US are affected by CF. In 2008, the median age of survival for patients in the US was 37.4 years according to data compiled by the Cystic Fibrosis Foundation. The major consequences of the disease are pancreatic insufficiency and reduced lung function. Lung disease accounts for about 90 percent of the mortality associated with CF. Patients with cystic fibrosis have dehydrated, thickened respiratory secretions that are difficult to clear and provide an attractive environment for bacteria, thus increasing the risk of infection and inflammation.

Pulmonary infections in CF patients are a chronic problem and represent the leading cause of exacerbations and mortality. P. aeruginosa is the leading pathogen in CF patients. The thick mucus in the lungs is ideally suited to bacteria, and individuals with CF are colonized and infected by bacteria from an early age; about 20 percent of children under 1 year of age and 80 percent of adult patients with CF have P. aeruginosa present in their sputum. Chronic infection with P. aeruginosa is associated with an accelerated decline in pulmonary function, more frequent exacerbations, and increased mortality in patients with CF.

SOURCE Bayer HealthCare Pharmaceuticals