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FDA OK's Unituxin; United Therapeutics wins pediatric voucher

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Executive Summary

United Therapeutics won FDA approval on 10 March of Unituxin (dinutuximab), a disialoganglioside, GD2-binding chimeric monoclonal antibody, in combination with granulocyte-macrophage colony-stimulating factor, interleukin-2 and 13-cis-retinoic acid to treat pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy. Shares of Silver Spring, Maryland-based United Therapeutics rose 2.7% on 10 March, before closing at $163.84, up $3.40, or 2.12%. The FDA also issued the company a rare pediatric disease priority review voucher, which confers priority review to a subsequent drug application that would not otherwise qualify for priority review. It is only the second time the US agency has awarded the voucher, which is designed to encourage development of new therapies aimed at preventing and treatment certain rare pediatric diseases. BioMarin won the first-ever rare pediatric disease voucher in February 2014, which it sold this past July for $67.5m to Regeneron and Sanofi.

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