Kids v Cancer Congratulates United Therapeutics on Receiving Priority Review Voucher Through the Creating Hope Act
WASHINGTON, March 10, 2015 /PRNewswire-USNewswire/ — Kids v Cancer is pleased to announce that today, United Therapeutics was awarded a Rare Pediatric Priority Review Voucher for Unituxin that treats neuroblastoma, a pediatric cancer. Kids v Cancer, a pediatric cancer non-profit, championed the Rare Disease Priority Review Voucher Program (also known as the Creating Hope Act), which created priority review vouchers as incentives for drug development for rare pediatric diseases, including pediatric cancers. The Creating Hope Act was based on a similar program that established priority review vouchers for tropical disease drugs. Priority review vouchers entitle the voucher holders to faster FDA review of any other drugs, including blockbuster drugs. In December, Knights Therapeutics sold a tropical disease priority review voucher, which would have the same valuation as a pediatric priority review voucher, to Gilead for $125M. United Therapeutic’s
Kids v Cancer, a pediatric cancer non-profit, championed the Rare Disease Priority Review Voucher Program (also known as the Creating Hope Act), which created priority review vouchers as incentives for drug development for rare pediatric diseases, including pediatric cancers. The Creating Hope Act was based on a similar program that established priority review vouchers for tropical disease drugs. Priority review vouchers entitle the voucher holders to faster FDA review of any other drugs, including blockbuster drugs. In December, Knights Therapeutics sold a tropical disease priority review voucher, which would have the same valuation as a pediatric priority review voucher, to Gilead for $125M. United Therapeutic’s
Priority review vouchers entitle the voucher holders to faster FDA review of any other drugs, including blockbuster drugs. In December, Knights Therapeutics sold a tropical disease priority review voucher, which would have the same valuation as a pediatric priority review voucher, to Gilead for $125M. United Therapeutic’s Unituxin is the second pediatric priority review voucher and the first pediatric cancer voucher to be awarded. ”
“Unituxin will enable kids with neuroblastoma to live longer,” said Nancy Goodman, Executive Director of Kids v Cancer. “We at Kids v Cancer are excited that the
“We at Kids v Cancer are excited that the Unituxin priority review voucher establishes a strong incentive to drug developers to pursue new pediatric cancer drugs.” “This is only the third drug that has received initial FDA approval for
“This is only the third drug that has received initial FDA approval for a pediatric cancer in over 20 years. In this era of exciting cancer research, we shouldn’t forget drug development for children’s illnesses. In comparison to the 900 drugs in the adult cancer pipeline, there are only a handful of drugs in development for pediatric cancers. We think pediatric priority review vouchers will chance that.”
Learn more at www.kidsvcancer.org
Kids v Cancer is a 501(c)(3) organization focused on changing the landscape of pediatric cancer research by identifying structural impediments at key junctures in the research process – new drugs, tissue donation and access to funding – and developing strategies to address them.
SOURCE Kids v Cancer
PDF Format: Article