Orphan designation will give lenalidomide (Revlimid) access to the centralized procedure for the application for marketing approval, reduce fees associated with applying for marketing approval and protocol assistance and provide 10 years of market exclusivity once approved for treatment of chronic lymphocytic leukemia (CLL).
Within the EU, Iceland and Norway, Revlimid is authorized for marketing and, in combination with dexamethasone, is indicated for the treatment of multiple myeloma patients who have received at least one prior therapy.
Graham Burton, senior vice president, global regulatory affairs and pharmacovigilance for Celgene, said: “The decision by the European Commission to designate Revlimid as an orphan medicinal product for treatment of chronic lymphocytic leukemia supports our efforts to move Revlimid as quickly as possible through the clinical and regulatory development process worldwide.”