The Israeli Ministry of Health has granted marketing authorization for oral, once-daily ORLADEYO® (berotralstat) to prevent attacks of HAE in adults and pediatric patients 12 years of age and older in Israel.
“We continue to make significant progress in bringing our oral, once-daily prophylactic therapy to many HAE patients around the world,” says Charlie Gayer, Chief Commercial Officer of BioCryst Pharmaceuticals, Inc. “With today’s announcement, we look forward to working with our partner Neopharm to launch ORLADEYO in Israel.”
“The approval of ORLADEYO is a major advancement for the HAE community in Israel. We are proud to partner with BioCryst to bring this oral therapy to patients who are in search of a less burdensome treatment option to help manage their disease,” says Efi Shnaidman, General Manager of Neopharm Israel.
Neopharm Group has the exclusive rights to commercialize ORLADEYO in Israel.
ORLADEYO was safe and well tolerated in clinical trials. The most frequently reported adverse reactions in patients receiving ORLADEYO compared with placebo were back pain and gastrointestinal reactions. The gastrointestinal reactions generally occurred early after initiation of treatment with ORLADEYO, became less frequent with time, and typically self-resolved.
(Source: BioCryst)
