08:33 AM EDT, 05/14/2025 (MT Newswires) -- BioCryst Pharmaceuticals ( BCRX ) said Wednesday that the US Food and Drug Administration has accepted and granted priority review to its new drug application for Orladeyo, or berotralstat, to treat hereditary angioedema in children 2 to 11 years old.

The company said the FDA has set a target action date of Sept. 12.

The application was supported by interim data from a clinical trial showing that Orladeyo was well-tolerated with consistent safety profile and led to a sustained reduction in attack rates in the target age group, according to BioCryst.

BioCryst said it has also submitted a line extension application with the European Medicines Agency for the use of Orladeyo oral granules in hereditary angioedema patients aged 2 to 11. Additional filings in other markets, including Japan and Canada, are being planned, the company added.

Orladeyo is currently approved for adults and pediatric patients 12 years and older in over 30 countries, including the US, the company said.