WAYNE, N.J. The Food and Drug Administration has given orphan drug designation to an investigational treatment for cystic fibrosis made by Bayer Healthcare Pharmaceuticals, Bayer announced Thursday.
The FDA gave the designation to the ciprofloxacin dry-powder inhaler for managing pulmonary infection by Pseudomonas aeruginosa bacteria in cystic fibrosis patients. The drug, formulated using Novartis’ proprietary PulmoSphere technology, is currently in phase 2 clinical trials.
The agency grants orphan drug designation to investigational treatments for diseases affecting fewer than 200,000 people in the United States. The designation gives the drug seven years’ market exclusivity rather than the usual five given to new drugs. Cystic fibrosis is a potentially fatal genetic disease affecting around 30,000 people in the United States. The median age of survival of CF patients in 2008 was less than 38 years.
“There continue to be significant unmet medical needs for people with cystic fibrosis,” Bayer HealthCare Pharmaceuticals VP and general manager for oncology and general medicine Shannon Campbell said. “We are pleased to receive the orphan drug designation from the FDA for ciprofloxacin [dry-powder inhaler], which we are researching as a potential treatment for management of pulmonary infections due to P. aeruginosa in CF patients.”