The Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) has granted orphan drug designation to Discovery Labs’ KL4 surfactant for the treatment of cystic fibrosis (CF).
The orphan designation provides for up to ten years of market exclusivity in the European Union (EU) for the drug product with the designated orphan indication. This period of market exclusivity initiates upon EU marketing authorization.
Dr Thomas F Miller, Discovery Labs' chief operating officer commented, “Discovery Labs has successfully procured orphan designations for several respiratory disease targets for our KL4 surfactant. We now have successfully secured orphan designations for CF treatment in both the U.S. and Europe. Our development experience to date suggests that CF may be a viable therapeutic target for our aerosolized KL4 surfactant technology.”
Discovery Laboratories, Inc. is a specialty biotechnology company with one focus – to create life-saving products for critical care patients with respiratory disease and improve the standard of care for pulmonary medicine.