Support for continued progress is critical for pediatric drug development

Researching and developing new medicinesfor children is a priority for the biopharmaceutical industry. Despite the scientific complexity and challenges inherent to developing treatments for our youngest patients, there has never been more progress in pediatric health outcomes.  The progress we are seeing in pediatric health outcomes is in part due to the advancement in medicines that have been specifically studied in and approved for use in children. To help advance the development of pediatric medicines, Congress, in a bipartisan fashion, passed provisions ultimately permanently reauthorization in two laws: thePediatric Research Equity Act (PREA) and the Best Pharmaceuticals for Children Act (BPCA). These policies work together to foster pediatric drug development, enabling biopharmaceutical companies to continue making significant investments in critical research areas for children.  The BPCA has been successful in advancing pediatric research.  For example, ibrutinib was awarded BPCA pediatric exclusivity based on the sponsor’s research into use of the drug in pediatric chronic graft-versus-host disease (cGVHD) patients. After ibrutinib was initially approved in 2017 for adult patients with cGVHD who have tried and failed on at leas t one previous medicine, the U.S. Food and Drug Administration (FDA) issued a BPCA written request to the sponsor for studies in pediatric cGVHD patients. In August of 2022, the FDA approved the use of this medicine ...
Source: The Catalyst - Category: Pharmaceuticals Authors: Tags: Medicines in Development Research and Development Pediatrics Government Price Setting Source Type: news