Orphan Drug Designation

Among Active Biotech’s projects, tasquinimod has been granted orphan drug designation for the treatment of multiple myeloma and myelofibrosis by the FDA.

The orphan drug designation is implemented to promote the development of drugs that can provide significant benefits to patients suffering from rare conditions.To qualify for orphan designation, a medicine must meet several criteria, such as being intended for a life-threatening or chronically debilitating disease. Additionally, the condition must be rare, and the medicine must offer a significant benefit to the patients suffering from it. Orphan drug status provides for seven to ten years of market exclusivity against competition, as well as certain incentives. Further information about orphan drugs can be found on the websites of the EMA or FDA.