BioCryst Receives UK Approval of ORLADEYO™ (berotralstat), First Oral, Once-daily Therapy to Prevent Attacks in Hereditary Angioedema Patients

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[{"type":"text","content":"RESEARCH TRIANGLE PARK, N.C., May 12, 2021 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for oral, once-daily ORLADEYO™ (berotralstat) for the routine prevention of recurrent hereditary angioedema (HAE) attacks in HAE patients 12 years and older. “HAE UK welcomes the decision from the MHRA to grant marketing authorization for berotralstat in the UK. Hereditary angioedema is an unpredictable and life-threatening condition which causes significant emotional and economic burdens on people with HAE and their families and careers. These burdens negatively impact their mental health and well-being, on top of the physical demands of living with a chronic condition. An oral therapy that shows effective control of HAE attacks will provide a different treatment choice for clinicians and patients and will assist in improving the quality of life of those living with the condition,” said Laura Szutowicz, chief executive officer of HAE UK. “This is a significant milestone in furthering our ability to meet the needs of more patients living with HAE. As the first oral, once-daily therapy proven to reduce the number of HAE attacks, today’s news has the potential to offer a convenient new treatment option to improve the lives and outcomes of patients with HAE,” said Dr. Sorena Kiani, consultant immunologist at Barts Health NHS Trust. A decision from the National Institute for Health and Care Excellence (NICE) and Scottish Medicines Consortium (SMC) for use of ORLADEYO under the UK’s National Health Service (NHS) is anticipated in the fourth quarter of 2021. “With the approval of the first oral, once-daily treatment in the UK, BioCryst continues to bring ORLADEYO to HAE patients and their families around the world,” said Jon Stonehouse, president and chief executive officer of BioCryst. In the pivotal Phase 3 APeX-2 trial, ORLADEYO significantly reduced attacks at 24 weeks, and this reduction was sustained through 48 weeks. HAE patients who completed 48 weeks of treatment (150 mg) saw reductions in their HAE attack rates, from a mean of 2.9 attacks per month at baseline to a mean of 1.0 attacks per month after 48 weeks of therapy. In the long-term open label APeX-S trial, patients completing 4...

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