BioCryst Announces Approval of ORLADEYO (berotralstat) by the Israeli Ministry of Health
RESEARCH TRIANGLE PARK, N.C., Nov. 28, 2022 (GLOBE NEWSWIRE) -- BioCryst
Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the Israeli Ministry of Health has granted marketing authorization for oral, once-daily ORLADEYO (berotralstat) to prevent attacks
of hereditary angioedema (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,” said Charlie Gayer, chief commercial officer of BioCryst. “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,” said 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.
About ORLADEYO (berotralstat)
ORLADEYO (berotralstat) is the first and only oral therapy designed specifically to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years and older. One capsule of ORLADEYO per day works to prevent HAE attacks by decreasing the activity of plasma kallikrein.
U.S. Indication and Important Safety Information
ORLADEYO (berotralstat) is a plasma kallikrein inhibitor indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older.
Limitations of use
The safety and effectiveness of ORLADEYO for the treatment of acute HAE attacks have not been established. ORLADEYO should not be used for the treatment of acute HAE attacks. Additional doses or dosages of ORLADEYO higher than 150 mg once daily are not recommended due to the potential for QT prolongation.
IMPORTANT SAFETY INFORMATION
An increase in QT prolongation was observed at dosages higher than the recommended 150 mg once-daily dosage and was concentration dependent.