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BioCryst Receives European Commission Approval of ORLADEYO™ (berotralstat), First Oral, Once-daily Therapy to Prevent Attacks in Hereditary Angioedema Patients
RESEARCH TRIANGLE PARK, N.C., April 30, 2021 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the European Commission
About this update from Biocryst Pharmaceuticals, Inc.
[{"type":"text","content":"RESEARCH TRIANGLE PARK, N.C., April 30, 2021 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the European Commission (EC) has approved oral, once-daily ORLADEYO™ (berotralstat) for the prevention of recurrent hereditary angioedema (HAE) attacks in HAE patients 12 years and older. “As the first targeted oral prophylactic therapy approved in Europe, ORLADEYO represents a major advance in treatment for HAE patients who have been waiting for a preventive therapy. Physicians will be delighted to discuss this new option with their patients,” said Emel Aygören-Pürsün, M.D., head of the HAE Center at the University Hospital in Frankfurt. “ORLADEYO offers people with HAE in Europe and their physicians the first orally administered non-steroidal option for preventing HAE attacks and represents a vitally important and most welcome step in making more treatment options available,” said Henrik Balle Boysen, executive vice president and chief operating officer of HAE International, a global non-profit network of patient associations dedicated to improving the lives of people with HAE. The EC approval of ORLADEYO is applicable to all European Union member states plus Iceland, Norway and Liechtenstein. BioCryst has its European commercial team in place and expects to launch ORLADEYO this quarter in Germany, with launches in other European markets to follow. HAE patients in France currently have access to ORLADEYO through an Autorisation Temporaire d'Utilisation de cohorte (cohort ATU). In the United Kingdom, HAE patients also currently have access to ORLADEYO through an approved early access to medicines scheme (EAMS). A marketing authorization application (MAA) has been submitted to the Medicines and Healthcare products Regulatory Agency (MHRA). Under the new European Commission Decision Reliance Procedure, the MHRA will aim to complete the review of the UK MAA as soon as possible following the EC approval decision. “Most European HAE patients today treat their disease with on-demand therapy or androgens and we believe the approval of oral, once-daily ORLADEYO provides an exciting new opportunity for these patients to reduce their burden of therapy by moving to prophylaxis with ORLADEYO,” said Jon Stonehouse, president and chief executive officer of BioCryst. “We saw tremendous enthusiasm and participatio...