Swissmedic grants marketing authorization for oral, once-daily ORLADEYO® (berotralstat) from BioCryst Pharmaceuticals, Inc. for the routine prevention of recurrent 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,” says Henrik Balle Boysen, Executive Vice President and COO of HAEi.
“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,” says Waldemar Heiduk, CEO 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.