Aug 18, 2022

Durham, North Carolina, UNITED STATES RESEARCH TRIANGLE PARK, N.C., Aug. 18, 2022 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the Saudi Food and Drug Authority (SFDA) has approved oral, once-daily ORLADEYO® (berotralstat) to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years of age and older in Saudi Arabia. “There is a significant need for new treatment options for HAE in Saudi Arabia. With this approval, we continue to deliver on our commitment to bringing our oral, once-daily prophylactic therapy to as many HAE patients around the world as possible,” said Charlie Gayer, chief commercial officer of BioCryst. In September 2021, BioCryst entered into a supply and distribution agreement with NewBridge Pharmaceuticals, which also covers the Gulf Cooperation Council (GCC) and Iraq. NewBridge Pharmaceuticals, headquartered in Dubai, United Arab Emirates (UAE), is a regional specialty company with a comprehensive pharmaceutical platform of services and expertise, established to bridge the access gap and partner with global pharma and biotech companies to in-license and commercialize U.S. Food and Drug Administration or European Medicines Agency approved innovative therapeutics that address unmet medical needs into the Middle East and North Africa (MENA) regions. “This marks the second market in the MENA region in which ORLADEYO has been approved for patients living with HAE, building on the approval in the UAE last year. We are pleased with the decision from the Saudi FDA and we are committed to continuing our work with BioCryst to bring this important therapy to patients in the GCC who are in search of a more optimal treatment option to help manage their HAE,” said Joe Henein, president and chief executive officer of NewBridge Pharmaceuticals. 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 INDICATION 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. The most common adverse reactions (≥10% and higher than placebo) in patients receiving ORLADEYO were abdominal pain, vomiting, diarrhea, back pain, and gastroesophageal reflux disease. A reduced dosage of 110 mg taken orally once daily with food is recommended in patients with moderate or severe hepatic impairment (Child-Pugh B or C) and in patients taking chronically administered P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) inhibitors (eg, cyclosporine). Berotralstat is a substrate of P-gp and BCRP. P-gp inducers (eg, rifampin, St. John’s wort) may decrease berotralstat plasma concentration, leading to reduced efficacy of ORLADEYO. The use of P-gp inducers is not recommended with ORLADEYO. ORLADEYO at a dose of 150 mg is a moderate inhibitor of CYP2D6 and CYP3A4. For concomitant medications with a narrow therapeutic index that are predominantly metabolized by CYP2D6 or CYP3A4, appropriate monitoring and dose titration is recommended. ORLADEYO at a dose of 300 mg is a P-gp inhibitor. Appropriate monitoring and dose titration is recommended for P-gp substrates (eg, digoxin) when coadministering with ORLADEYO. The safety and effectiveness of ORLADEYO in pediatric patients <12 years of age have not been established. There are insufficient data available to inform drug-related risks with ORLADEYO use in pregnancy. There are no data on the presence of berotralstat in human milk, its effects on the breastfed infant, or its effects on milk production. To report SUSPECTED ADVERSE REACTIONS, contact BioCryst Pharmaceuticals, Inc. at 1-833-633-2279 or FDA at 1-800-FDA-1088 or  www.fda.gov/medwatch .