The FDA has granted orphan drug designation to an Airway Therapeutics drug to treat bronchopulmonary dysplasia (BPD) in extremely premature babies. Airway Therapeutics is a startup company funded by Cincinnati Children’s Hospital Medical Center and CincyTech.
The company has developed a surfactant protein – called recombinant human surfactant protein D – which preclinical data show is effective in preventing BPD. Airway Therapeutics is currently raising money to manufacture its protein, and is conducting additional toxicology studies on animals.
“The ruling really provides a foundation for our project, which is important,” said CEO Marc Salzberg, who noted the company learned on Tuesday that the US Food and Drug Administration approved its application for orphan status.
