Community Statement
August 21, 2025
Dear HAE community,
Today, we are proud to announce that the U.S. Food and Drug Administration (FDA) has approved DAWNZERA™ (donidalorsen), a prescription medicine used to prevent hereditary angioedema patients (HAE) attacks in adults and children 12 years of age and older. This achievement – the first and only RNA-targeted prophylactic treatment for HAE – would not have been possible without the support of the patient community.
Please see Important Safety Information on the following page, as well as Full Prescribing Information and Patient Information for DAWNZERA, also available at DAWNZERA.com.
A link to the full press release announcing the approval can be found here.
We know that individuals with HAE and their families will have questions. We recommend that community members speak with their doctor regarding medical questions about HAE and treatment decisions.
Ionis is committed to helping people access the medicines they are prescribed and will offer services for people prescribed DAWNZERA through Ionis Every Step™. The Ionis Every Step program is designed to support individuals with HAE and their providers on every step of their treatment journey after DAWNZERA is prescribed. In addition to insurance support and financial assistance programs, Ionis Every Step offers help with navigating the insurance process and injection training. For more information about Ionis Every Step, please call 1-844-444-4305, Monday to Friday, 8:00 am - 8:00 pm ET.
We are deeply grateful to the individuals, families, clinical trial sites, and advocacy organizations who participated in and supported enrollment in our clinical trials. Thank you for being a vital part of this journey.
Sincerely,
Ionis Patient Advocacy
For additional questions, please contact padvocacy@ionis.com.
INDICATION
DAWNZERA™ (donidalorsen) is a prescription medicine used to prevent hereditary angioedema (HAE) attacks in adults and children 12 years of age and older.
It is not known if DAWNZERA is safe and effective in children under 12 years of age.
IMPORTANT SAFETY INFORMATION
Do not use DAWNZERA if you have had a serious allergic reaction, including anaphylaxis to donidalorsen or any of the ingredients in DAWNZERA.
Before using DAWNZERA, tell your healthcare provider about all of your medical conditions, including if you: are pregnant or plan to become pregnant, are breastfeeding or plan to breastfeed. It is not known if DAWNZERA can harm your unborn baby, or if it passes into your breast milk and if it can harm your baby.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What are the possible side effects of DAWNZERA?
DAWNZERA can cause serious side effects including allergic reactions. Allergic reactions can include rash, trouble breathing, chest pain, fainting, dizziness, feeling lightheaded, swelling of the face, lips or tongue, and itching. Stop using DAWNZERA and call your healthcare provider or get emergency help right away if you have any of these symptoms.
The most common side effects of DAWNZERA include injection site reactions (such as redness or pain at the injection site), upper respiratory tract infection, urinary tract infection, abdominal discomfort.
These are not all the possible side effects of DAWNZERA. Tell your healthcare provider or treatment team about any side effects you may have.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/safety/medwatch, or call 1-800-FDA-1088.