BioCryst Pharmaceuticals, Inc.‘s new drug submission for Orladeyo (berotralstat) has been accepted for review by Health Canada for the prevention of recurrent attacks in patients with HAE 12 years and older. Swissmedic has also 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,” says Jon Stonehouse, President and CEO 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.”