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BioCryst Announces Approval of ORLADEYO® (berotralstat) in Saudi Arabia
RESEARCH TRIANGLE PARK, N.C., Aug. 18, 2022 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the Saudi Food and Drug
About this update from Biocryst Pharmaceuticals, Inc.
[{"type":"text","content":"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 patient...