Creating Hope Act Sponsors React to FDA Approval of Pediatric Cancer Treatment

Press Release

Today the Food and Drug Administration announced the approval of a pediatric cancer drug developed by United Therapeutics and issued a priority review voucher under a program established by the Creating Hope Act. The drug, Unituxin, developed to treat patients with neuroblastoma, is only the third drug to receive initial FDA approval for a pediatric cancer in the last 20 years. The Creating Hope Act was signed into law in 2011, and was sponsored by Congressmen Chris Van Hollen (D-MD), Michael McCaul (R-TX), and G.K. Butterfield (D-NC).

"The Creating Hope Act was designed to spur both lifesaving cures for children and new innovations that help American companies grow and create jobs," Congressman Van Hollen said. "I'm glad a Maryland business is the latest to benefit from this program to kick-start investment in treatments and cures for children and families affected by cancer."

Congressman McCaul said, "The scientists and doctors who developed this drug deserve credit and recognition for this amazing achievement. Too many children suffer from neuroblastoma and for them and their families the development of the first FDA approved treatment in decades is welcome news. I am proud that the Creating Hope Act played an important role in this process. The voucher program established by this law has once again demonstrated its value. I look forward to working with my colleagues to make this program permanent for children with all rare diseases, such as pediatric cancer and sickle cell disease."

"I'm pleased to learn that the Creating Hope Act is fulfilling its purpose of advancing drugs for rare pediatric diseases to market," said Congressman Butterfield. "Since its enactment, less than four years ago, we've already seen two pediatric drugs receive approval by the FDA. I look forward to more drugs gaining approval and more children receiving the treatment they need."

The Creating Hope Act provides market incentives to pharmaceutical companies to develop new drugs for children with rare pediatric diseases, such as childhood cancers and sickle cell. This is the second voucher awarded under the law.

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