Alitair Bronchiectasis Treatment Gains Orphan Status

Alitair Pharmaceuticals has received Orphan Drug Designation from the FDA for Erdosteine, for the treatment of bronchiectasis. Erdosteine is a mucolytic with antibacterial, anti-inflammatory, and antioxidant properties.

Erdosteine is currently approved for the treatment of COPD and chronic bronchitis in 50 countries outside of the U.S. Because the company currently has an open IND for Erdosteine for a different indication, it will be able to go directly into the clinic after a pre-IND meeting with FDA. Bronchiectasis is a condition in which the lungs produce excessive amounts of mucus. Cystic fibrosis is the best known disease that causes bronchiectasis.

Orphan drug designation is granted by the FDA to drug therapies intended to treat a rare disease or condition affecting fewer than 200,000 patients in the U.S. The designation provides tax incentives to offset development costs, an exemption from FDA user fees, and the potential for a seven-year period of market exclusivity in the U.S. after product approval. Orphan drugs often command premium pricing and have smaller marketing costs than conventional drugs, making them attractive targets for development.