DAWNZERA™ (donidalorsen) approved in the European Union for hereditary angioedema (HAE)

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[{"type":"text","content":" CARLSBAD, Calif.--(BUSINESS WIRE)--\nIonis Pharmaceuticals, Inc. (Nasdaq: IONS) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced that the European Commission (EC) has approved DAWNZERA™ (donidalorsen) in the European Union (EU) for the routine prevention of recurrent attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 years and older. The approval follows the positive opinion of the Committee for Medicinal Products for Human Use.\n\n\nThe approval is based on positive results from the Phase 3 OASIS-HAE and OASISplus studies, in which DAWNZERA demonstrated positive results across multiple measures of disease including significant and sustained reduction in mean monthly HAE attack rate, with 94% overall mean monthly attack rate reduction at one year in the OASISplus open-label extension study. DAWNZERA is self-administered via subcutaneous autoinjector every four or eight weeks.\n\n\n“The EU approval of DAWNZERA is an important milestone that reflects our ongoing commitment to bring this innovative medicine to people in need across the globe,” said Brett P. Monia, Ph.D., chief executive officer, Ionis. “As the first and only RNA-targeted therapy for HAE, we believe DAWNZERA has the potential to become the prophylactic therapy of choice for many patients across the EU. We extend our deepest gratitude to the patients, families and investigators who participated in our clinical trials and helped make this achievement possible.”\n\n\nHAE is a rare and potentially life-threatening genetic condition that involves recurrent attacks of severe swelling (angioedema) in various parts of the body, including the hands, feet, genitals, stomach, face and/or throat. HAE is estimated to affect about 1 in 50,000 people worldwide.\n\n\n“We are proud of the decision from the European Commission to authorize the use of DAWNZERA in HAE. This represents another key milestone in the collaboration between Otsuka and Ionis which aims to address unmet need in a challenging rare disease,” said Andy Hodge, President and CEO at Otsuka Pharmaceutical Europe Ltd. “We would like to thank all those at Otsuka and Ionis whose commitment has helped us introduce this medicine to patients.”\n\n\nDAWNZERA was approved by the U.S. Food and Drug Administration in August 2025 for prophylaxis to prevent attacks of HAE in adult and pediatric...

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