Ionis Pharmaceuticals received FDA approval for DAWNZERA™ (donidalorsen) as the first RNA-targeted prophylactic treatment for hereditary angioedema (HAE).
DAWNZERA demonstrated significant reduction in HAE attack rates and offers extended dosing intervals, providing a promising treatment option for patients.
The approval is based on positive Phase 3 trial results showing substantial efficacy and safety of DAWNZERA in managing HAE symptoms.
Groundbreaking Approval
First and only RNA-targeted medicine approved for HAE, offering long dosing intervals and strong efficacy.
Clinical Efficacy
DAWNZERA significantly reduced HAE attack rates by 81% compared to placebo and demonstrated long-term disease control.
Patient Preference
84% of patients preferred DAWNZERA over previous treatments due to better disease control, convenience, and fewer side effects.
- DAWNZERA's approval marks a significant advancement in HAE treatment options, providing patients with a promising prophylactic option.
- The Phase 3 study results demonstrate the effectiveness of DAWNZERA in reducing HAE attack rates and improving patient quality of life.
Ionis Pharmaceuticals celebrates the FDA approval of DAWNZERA as a pivotal moment in advancing treatment options for HAE patients, reflecting the company's commitment to innovation and patient care.