Sanofi And Regeneron Buy Review Voucher | Chemical & Engineering News
Volume 92 Issue 31 | p. 19 | Concentrates
Issue Date: August 4, 2014

Sanofi And Regeneron Buy Review Voucher

Department: Business
Keywords: rare diseases, drug approvals, FDA review

Sanofi and Regeneron Pharmaceuticals have paid BioMarin $67.5 million for a voucher that will speed up FDA review of alirocumab, a monoclonal antibody the two are developing as a cholesterol-lowering agent. Under a 2012 law, FDA issues such vouchers to firms that develop drugs for rare pediatric diseases. BioMarin obtained its voucher in February when it won approval of Vimizim, which treats Morquio A syndrome, a rare pediatric disease. With the voucher, Sanofi and Regeneron will enjoy a six-month review instead of the standard 10-month review. The sale is the first for the pediatric priority review voucher program.

 
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