Aradigm receives FDA orphan drug designation

Aradigm previously received orphan drug designation for the same formulation of ciprofloxacin for the management of cystic fibrosis in April 2006.

Aradigm's liposomal ciprofloxacin is an aerosolized formulation that was designed to prolong its anti-infective properties in the lung in order to treat the related infections found in bronchiectasis (BE) and cystic fibrosis, while minimizing the concentration of the drug in the rest of the body.

“We are very pleased with the orphan drug designation for an additional indication for our inhaled liposomal ciprofloxacin formulation. The orphan drug designation continues to support our strategy to help patients with severe respiratory disease,” said Babatunde Otulana, senior vice president of Development at Aradigm.

Orphan drug designation is given to therapies for diseases that affect fewer than 200,000 patients. As an orphan drug, liposomal ciprofloxacin is eligible for tax credits, as well as assistance from the FDA. The designation also provides the opportunity to obtain market exclusivity for seven years.