Novartis Coartem NDA May Lead to First Priority Review Voucher
This article was originally published in RPM Report
Malaria drug receives "priority" status from FDA, which should mean Novartis receives a voucher for priority designation on another product under new incentive program for tropical disease research. December application deadline also sets a deadline for FDA to defi ne key elements of how PRVs will work.
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One of the “innovation” pieces of the FDA Safety & Innovation Act is a priority review voucher program for drugs to treat pediatric rare diseases. The new PRV is designed to avoid some of the glitches that have complicated the value of the program in tropical diseases—but it can’t avoid the core problem inherent in trying to capture the value of a priority review by legislative fiat.
The End of Priority Review Vouchers? Reactions to Novarits' Ilaris Panel and Incentives for Tropical Disease Research
A supplemental BLA submitted by Novartis is the first product to use a priority review voucher to support the review. After a rejection by an advisory committee, will it also be the last? Advocates for tropical disease reseach weigh in with perspectives on the vocuher and other incentives.
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