EU orphan status for Celgene's Revlimid

US firm Celgene's Swiss subsidiary, Celgene International, say that Revlimid (lenalidomide) has been granted Orphan Medicinal product designation by the European Commission for treatment of chronic lymphocytic leukemia following the favorable opinion of the European Medicines Agency's (EMEA) Committee for Orphan Medicinal Products.

Orphan designation will give lenalidomide 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. This is a hematological cancer that affects around 165,000 people in the European Union, based on an estimated prevalence of 3.5 per 10,000.

Graham Burton, senior vice president, global regulatory affairs and pharmacovigilance for Celgene Corp, said: "we continue to be encouraged by the growing body of published and presented data on Revlimid by key opinion leaders at major medical meetings, and based on these findings, we are committed to accelerating wherever possible our efforts to help address the unmet medical needs of patients with chronic lymphocytic leukemia worldwide."