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The price of priority review: $67.5 million

Nature Biotechnology volume 32, page 973 (2014)Cite this article

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BioMarin secured its priority review voucher (PRV) in February 2014 when its rare diseases drug Vimizim (elosulfase alfa) was approved for Morquio A syndrome, a lysosomal storage disorder. These vouchers were conceived as tools to give incentives for drug development in underserved areas; they can be traded and their value lies in their potential to accelerate the review of mainstream drugs, potentially adding millions in sales for the drug's sponsor. BioMarin's is the first—and remains the only—voucher issued for a drug to treat a pediatric rare disease, under FDA's Safety and Innovation Act of 2012. Before BioMarin earned theirs, the agency issued three other PRVs under the rare tropical diseases program, created under 2007 legislation.

But until now, the tropical diseases program has been viewed with skepticism. Novartis, the first company to deploy a PRV in 2011, used it on gouty arthritis candidate ACZ885 (canakinumab). The Basel-based pharma paid a higher user fee in the process and found that it simply got rejected faster (Nat. Biotechnol. 29, 958, 2011).

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    Melanie Senior

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Senior, M. The price of priority review: $67.5 million. Nat Biotechnol 32, 973 (2014). https://doi.org/10.1038/nbt1014-973

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