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EU Regulatory Authorities Grant Orphan Status To Eisai Co Ltd's Lenvatinib For Treatment Of Radioiodine-Refractory Differentiated Thyroid Cancer


Monday, 6 May 2013 07:03pm EDT 

Eisai Co Ltd announced that the investigational multi-tyrosine kinase inhibitor (TKI), lenvatinib (development code: E7080), has been granted orphan drug designation (ODD) for the treatment of follicular and papillary thyroid cancer by the European Commission. ODD is for medicines developed for the diagnosis, prevention or treatment of rare diseases that are life-threatening or very serious. In the European Union (EU), a disease is defined as rare if it affects fewer than five in 10,000 people across the EU. Lenvatinib received ODD from the Swiss agency for therapeutic products, Swissmedic, on March 13, 2013 for the treatment of follicular (FTC), medullary (MTC) and anaplastic (ATC) thyroid cancer. Orphan drug status was granted in February 2013 by the US Food and Drug Administration (FDA) in the treatment of FTC, MTC and ATC thyroid cancer. Japan's Ministry of Labour, Health and Welfare also granted ODD for thyroid cancer in August 2012. 

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