By: IPP Bureau
Last updated : January 28, 2026 7:50 am
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
Ionis Pharmaceuticals and Otsuka Pharmaceutical have announced that the European Commission has approved DAWNZERA (donidalorsen) for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 and older.
The move follows a positive recommendation from the Committee for Medicinal Products for Human Use.
The approval is grounded in results from the Phase 3 OASIS-HAE and OASISplus studies, which showed DAWNZERA significantly reduced mean monthly HAE attack rates. In the OASISplus open-label extension, patients saw a 94% overall mean monthly attack rate reduction at one year. DAWNZERA is self-administered via subcutaneous autoinjector every four or eight weeks.
“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, CEO of 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.”
HAE is a rare, potentially life-threatening genetic disorder that causes recurrent, severe swelling in areas including the hands, feet, genitals, stomach, face, and throat. It affects roughly 1 in 50,000 people worldwide.
“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.”
DAWNZERA was previously approved by the US Food and Drug Administration in August 2025 for HAE prophylaxis in patients 12 and older. Otsuka holds exclusive rights to distribute DAWNZERA across Europe and the Asia Pacific. The approval triggers a $15 million milestone payment to Ionis, along with tiered royalties up to 30% on net sales.
DAWNZERA is an RNA-targeted therapy designed to inhibit plasma prekallikrein (PKK), a key player in inflammatory mediators that trigger HAE attacks. It is approved in both the U.S. and EU for prophylaxis in patients 12 years and older.