Pharma Focus Asia

BioCryst Announces Approval of ORLADEYO® (berotralstat) by Swissmedic

Wednesday, June 08, 2022

BioCryst Pharmaceuticals, Inc. announced that Swissmedic has granted marketing authorization for oral, once-daily ORLADEYO® (berotralstat) for the routine prevention of recurrent hereditary angioedema (HAE) attacks in patients 12 years and older in Switzerland.

“ORLADEYO offers people with HAE in Switzerland and their physicians the first orally administered non-steroidal therapy for preventing HAE attacks and provides the community with another vitally important treatment option,” said Henrik Balle Boysen, executive vice president and chief operating officer of HAE International, a global non-profit network of patient associations dedicated to improving the lives of people with HAE.

“We have made significant progress in making ORLADEYO available to many patients in Europe since we received European Commission approval of our oral, once-daily prophylactic therapy last year,” said Waldemar Heiduk, chief executive officer of BioCryst Pharma Deutschland GmbH. “With today’s announcement, we look forward to launching ORLADEYO in Switzerland soon, pending finalization of our reimbursement plans.”

ORLADEYO was safe and well tolerated in clinical trials. The most frequently reported adverse reactions in patients receiving ORLADEYO compared with placebo were gastrointestinal reactions. These reactions generally occurred early after initiation of treatment with ORLADEYO, became less frequent with time and typically self-resolved.

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