Updated on 15 February 2013
FDA grants orphan drug status to Eisai cancer drug lenvatinib
Singapore: Eisai announced that the US FDA has granted orphan drug designation to its investigational drug lenvatinib (E7080) for follicular, medullary, anaplastic and metastatic or locally advanced papillary thyroid cancer.
Eisai's anti-cancer agent multi-kinase inhibitor lenvatinib mesylate (lenvatinib) had in August 2012 received orphan drug designation from Japan's Ministry of Labor, Health and Welfare for the treatment of thyroid cancer.
The Orphan Drug Act (ODA) allows FDA to grant orphan status to a drug that has the potential for the treatment, diagnosis or prevention of a rare disease or disorder that affects fewer than 200,000 people in the US.