Ceplene Receives Orphan-Drug Designation in Europe for AML

The European Commission (EC) granted Maxim Pharmaceuticals' Ceplene (histamine dihydrochloride) orphan-drug designation for the treatment of acute myeloid leukemia patients following adoption of a positive opinion by the Committee for Orphan Medicinal Products of the European Medicines Agency.

Orphan-drug status is granted by the EC to promote development of drugs to treat rare diseases or conditions. Orphan-drug designation in the European Union (EU) may provide several benefits, including 10 years marketing exclusivity throughout Europe for the therapeutic indication for which it was granted, facilitated access to the centralized procedure for the application for marketing approval, reduced fees associated with applying for marketing approval and protocol assistance, and access to EU research funding grants.