Benzinga | Aug 25, 2021 04:02PM EDT

BioCryst Announces Acceptance of Regulatory Applications for ORLADEYO (berotralstat) by Health Canada and Swissmedic

BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that the new drug submission for ORLADEYO(r) (berotralstat) has been accepted for review by Health Canada for the prevention of recurrent attacks in patients with hereditary angioedema (HAE) 12 years and older. The company also announced that Swissmedic has accepted BioCryst's marketing authorization application for ORLADEYO for review.



"We are making significant progress with our goal to bring ORLADEYO to HAE patients around the world," said Jon Stonehouse, president and chief executive officer of BioCryst. "Currently there are no targeted oral HAE therapies available in Canada or Switzerland for patients living with HAE. If approved, ORLADEYO has the potential to be an important new treatment option for Canadian and Swiss HAE patients and physicians."