BioCryst announces expected timescales for US filing of Orladeyo for pediatric use during R&D day
BioCryst Pharmaceuticals reported that it expects to submit a U.S. supplemental new drug application for the pediatric use of ORLADEYO in 2025. The announcement came during an update on the company’s pipeline at a Research and Development Day at the company’s Discovery Center of Excellence in Alabama, United States.
Jon Stonehouse, President and Chief Executive Officer of BioCryst, said: “The success we are achieving with ORLADEYO demonstrates that when we deliver a first-in-class or best-in-class medicine, we can change patients’ lives. We believe the combination of ORLADEYO, our exciting pipeline and our financial strength, position us to continue to make a big difference in patients’ lives, and that leads to sustainable growth for years to come.”
BioCryst provided an update on clinical trials of its pediatric formulation of Orladeyo. It indicated that the ongoing APeX-P clinical trial is assessing an oral granule formulation of ORLADEYO in pediatric HAE patients who are 2 to <12 years of age.
The company noted that approximately 40 percent of HAE patients have their first attack by five years of age and there are no current targeted oral therapies available for prophylaxis in children <12 years old.
(Source: BioCryst)
