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BioCryst Presents New Real-world Data Showing Reduced Attack Rates in Patients with HAE with Normal C1-inhibitor Following Long-term Treatment with ORLADEYO® (berotralstat)
– Additional analysis from APeX-S showed patients who self-reported HAE attack rates at baseline had a median attack rate of 0 attacks per month across
About this update from Biocryst Pharmaceuticals, Inc.
[{"type":"text","content":"– Additional analysis from APeX-S showed patients who self-reported HAE attack rates at baseline had a median attack rate of 0 attacks per month across 12-month period –\nRESEARCH TRIANGLE PARK, N.C., Nov. 10, 2023 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced new analyses of real-world use of oral, once-daily ORLADEYO® (berotralstat) leading to a reduction in monthly attack rates in patients with hereditary angioedema (HAE) who have normal C1-inhibitor (C1-INH) level and function. “There is a significant unmet need among people who live with HAE with normal C1-INH, and identifying optimal treatments has been challenging for these patients. These real-world observations suggest ORLADEYO can have a meaningful impact on the lives of people who have HAE with normal C1-INH. We look forward to continuing to evaluate our oral, once-daily prophylaxis as a treatment option for this subpopulation,” said Dr. Ryan Arnold, chief medical officer of BioCryst. The company also announced a new post-hoc analysis from the APeX-S clinical trial that showed a sustained reduction in HAE attacks compared to patients’ self-reported baseline attack rates. “The ability to compare patients’ treatment outcomes with their HAE attack rates at baseline is tremendously helpful to characterize the impact of a prophylactic therapy. While this analysis from APeX-S includes baseline attack rates that were retrospectively self-reported by patients, the findings are consistent with results previously reported from the pivotal APeX-2 trial, that long-term prophylaxis with ORLADEYO leads to a sustained reduction in attack rates and is an important therapeutic option for the prevention of HAE attacks,” said H. James Wedner, M.D., professor of medicine in the division of allergy and immunology at the John T. Milliken department of medicine at Washington University School of Medicine. The data are being presented at the 2023 Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology (ACAAI), which is being held at the Anaheim Convention Center in Anaheim, Calif., from November 9-13, 2023. BioCryst ACAAI 2023 Presentation Highlights The presentations at ACAAI include analyses from the APeX-S clinical study and real-world data from patients taking ORLADEYO in the United States. APeX-S was a Phase 2, open label, in...