Bayer lung infection drug gets orphan status

NEW YORK

Bayer HealthCare Pharmaceuticals said Thursday that it received orphan status for an inhaled drug intended to treat lung infections in cystic fibrosis patients.

Orphan drug status is granted by the Food and Drug Administration for drugs intended to treat rare diseases. Bayer said its drug also has orphan status in the European Union.

The company will get tax credits and assistance for designing studies of the drug, a powdered version of ciprofloxacin, along with extended market exclusivity if it is approved.

The drug is in mid-stage clinical testing to determine if it can improve the lung function of cystic fibrosis with a bacterial infection called Pseudomonas aeruginosa.

Bayer said about 30,000 people in the U.S. have cystic fibrosis. The disease causes blockages, infections and inflammation in the lungs. Lung infection is the top cause of death in cystic fibrosis patients.