BioCryst Pharmaceuticals, Inc. announced that oral, once-daily ORLADEYO (berotralstat) is now available for patients with a prescription in Germany.
ORLADEYO was approved by the European Medicines Agency (EMA) on April 30, 2021 for the prevention of recurrent hereditary angioedema (HAE) attacks in HAE patients 12 years and older. The full European Summary of Product Characteristics (SMPC) for ORLADEYO is available on the EMA website at www.ema.europa.eu.
“We have an experienced team in place in Germany that is excited and honored to bring the first oral, once daily therapy to HAE patients in Europe,” said Charlie Gayer, chief commercial officer of BioCryst. “Patients and physicians across Europe have told us about the significant need for a targeted oral therapy for HAE, and Germany is the first of many upcoming European launches for ORLADEYO.”