Issue Date: June 1, 2015
Sanofi Buys Drug Review Voucher
Sanofi will pay San Diego-based Retrophin $245 million for its pediatric disease priority review voucher. PRVs, which can speed up the review of a New Drug Application, were introduced by FDA to encourage development of drugs for rare and neglected pediatric diseases. Retrophin received its PRV in March with FDA’s approval of Cholbam, a treatment for kids and adults with bile acid synthesis disorders caused by single-enzyme defects. Last year, Regeneron paid BioMarin $67.5 million for a PRV; Regeneron and Sanofi later used it to shave four months off the review time for their cholesterol-lowering drug alirocumab. Sanofi isn’t saying how it plans to use the Retrophin PRV.
- Chemical & Engineering News
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