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Study Results
Significant reductions in hereditary angioedema (HAE) attacks
The safety and efficacy of DAWNZERA were evaluated in the primary study. Across 6 months, those who took DAWNZERA every 4 weeks saw 81% fewer attacks on average vs placebo (primary endpoint).*
In the primary study:
About 90% fewer
moderate-to-severe HAE attacks, HAE attacks requiring rescue medication, and HAE attacks requiring ER visits†
In the long-term safety study,
94% fewer attacks
on average after 1 year vs attack rate before beginning treatment‡
ER=emergency room.
*Reductions in HAE attacks were measured 24 weeks after their first dose.
†Average percentage (%) observed in people using DAWNZERA every 4 weeks. Moderate-to-severe HAE attacks and rescue medication use were secondary endpoints, and ER visits due to HAE attacks were an exploratory endpoint.
‡Across both dosing groups (every 4 weeks and every 8 weeks), secondary endpoint.
Safety and Side Effects
Safety and side effects seen with DAWNZERA
The most common side effects of DAWNZERA were injection-site reactions.§
These are not the only possible side effects of DAWNZERA. Tell your doctor if you have any side effect that bothers you or does not go away while taking DAWNZERA.
| Adverse reaction, n (%) | DAWNZERA every 4 weeks (n=45) | DAWNZERA every 8 weeks (n=23) | Placebo (n=22) |
|---|---|---|---|
| Injection-site reactions§|| | 11 (24) | 1 (4) | 1 (5) |
| Upper respiratory tract infection | 4 (9) | 2 (9) | 1 (5) |
| Urinary tract infection | 4 (9) | 2 (9) | 0 |
| Abdominal discomfort | 3 (7) | 0 | 0 |
Redness was the most common injection-site reaction.
In clinical trials, hypersensitivity reactions, including anaphylaxis, have occurred. Symptoms included generalized rash, shortness of breath, chest pain, and swelling around the mouth.
At 1 year, no new safety concerns were identified, and most side effects were mild or moderate.
§Injection-site reactions include: erythema (redness), discoloration, pain, pruritus (itching), induration (hardening or thickening of the skin), bruising, hematoma (localized bleeding under the skin), hypersensitivity, swelling, reaction, and urticaria (hives).
||All injection-site reactions were mild, nonserious, and the majority of them resolved without receiving any treatment.
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How DAWNZERA Works
The first treatment to use RNA technology for HAE attack prevention
HAE is a complex disease, and many everyday situations can trigger attacks, including heat, stress, and injury. However, attack triggers aren’t the underlying cause of HAE. In HAE type 1 and 2, C1-inhibitor (C1-INH) deficiency or dysfunction creates an imbalance of proteins involved in the kallikrein-kinin pathway (HAE pathway). This can lead to increased activation of plasma prekallikrein (PKK) and excess bradykinin production, which contributes to HAE attacks.
RNA technology has been used across many types of medical conditions for almost 30 years. It works by reducing, enhancing, or modifying proteins
DAWNZERA does not change DNA
DAWNZERA works by lowering plasma PKK, a protein in the HAE pathway that contributes to swelling
DAWNZERA restores balance to the HAE pathway by reducing production of plasma PKK in the liver, where it's produced
DAWNZERA is designed to work in 3 steps:
DAWNZERA is specifically targeted to the liver, where plasma PKK is made.
DAWNZERA finds and directs the breakdown of the message (called mRNA) that tells your body to make a protein called plasma PKK.
By targeting mRNA, DAWNZERA helps to control the pathway that leads to swelling.
Why does DAWNZERA target the liver?
Plasma PKK, a protein that plays a key role in swelling, is made in the liver. Therefore, DAWNZERA works in the liver to lessen plasma PKK in the blood and helps control the pathway that leads to swelling.
DNA=deoxyribonucleic acid; mRNA=messenger RNA; RNA=ribonucleic acid.