April 11, 2008--Celgene International Sarl today announced that amrubicin hydrochloride has been designated as an orphan medicinal product by the European Commission (EC) for the treatment of small cell lung cancer following the favorable opinion of the European Medicines Agency's (EMEA) Committee for Orphan Medicinal Products.
Criteria for designation of orphan medicinal product require that the product be intended for the treatment of life-threatening or serious conditions that are rare and affect not more than 5 in 10,000 persons in the EU. In the European Union, small cell lung cancer affects more than 57,000 people and approximately 34,000 new cases of the disease will be diagnosed this year.
Orphan medicinal product designation is granted by the EC to provide special incentives for sponsors planning to test a product for use in a rare disease or condition. These incentives include eligibility for protocol assistance and possible exemptions or reductions of certain regulatory fees during development or at the time of application for marketing approval. Orphan designation will provide amrubicin with 10 years of marketing exclusivity following marketing approval for the treatment of small cell lung cancer.
"The decision by the European Commission to designate amrubicin hydrochloride an orphan medicinal product continues our efforts to deliver innovative therapies worldwide to patients in areas of great unmet medical need such as solid tumor cancers," said Graham Burton M.D., SVP, Global Regulatory Affairs and Pharmacovigilance for Celgene Corporation.
In March 2008, the Company also announced that the U.S. Food and Drug Administration has granted orphan drug designation for amrubicin in the treatment of small cell lung cancer.
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