BioCryst Pharmaceuticals announced the FDA approved a supplemental new drug application for RAPIVAB.
BioCryst Pharmaceuticals (NASDAQ:BCRX) announced the US Food and Drug Administration (FDA) approved a supplemental new drug application for RAPIVAB.
As quoted in the press release:
The pediatric approval was based on the interim analysis of an ongoing pediatric clinical study. Those results will be presented at the upcoming ID Week 2017 meeting in San Diego.
“This approval represents the first new influenza antiviral for pediatric use in over 10 years,” said Jon P. Stonehouse, President & Chief Executive Officer. “RAPIVAB provides another treatment option for pediatric patients with acute, uncomplicated influenza and represents another important milestone for BioCryst.”