The orphan drug status will become effective if the European Commission approves this recommendation. Amongst other benefits, the designation provides EU market exclusivity for up to ten years in the given indication.
The orphan drug program of the EMEA is designed to promote the development of drugs to treat life-threatening or very serious conditions that affect no more than five in every 10,000 people in the European Union.
1D09C3 is currently in a phase I clinical program that is evaluating the antibody in patients with relapsed or refractory B-cell lymphomas, including Hodgkin’s and non-Hodgkin’s lymphomas, who have failed prior standard therapy.
The drug was previously granted orphan medicinal product designation by the European Commission for Hodgkin’s lymphoma and chronic lymphocytic leukemia, a type of non-Hodgkin’s lymphoma.