Wednesday, March 29, 2017 12:01:32 PM
"The Priority Review Voucher program was introduced to encourage companies to develop drugs for rare pediatric conditions or neglected tropical diseases. If the company’s drug gets approved for a pediatric or neglected tropical disease, the FDA can give them a voucher that they can then use for future drug applications. A priority review designation by the FDA means the drug will be reviewed in 6 months instead of the standard 10 months. And the vouchers can be applied to ANY future drug application by the company. Normally, a priority review designation would only be given to a drug that is for a 'serious condition' and has demonstrated 'the potential to be a significant improvement in safety and effectiveness'.
The Priority Review Voucher is also transferable and that is what United Therapeutics decided to do with their voucher—sell it. And Abbvie believes that getting one of their drugs to market 4 months earlier is worth $350 million.
United Therapeutics received the Pediatric Disease Priority Review Voucher when dinutuximab was approved by the FDA for the treatment of neuroblastoma, a rare pediatric disease in March, 2015."
http://www.raredr.com/news/abbvie-buys-priority-review-voucher-for-350-million
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