Looking to start a preventative
treatment? Meet DAWNZERA
treatment? Meet DAWNZERA
DAWNZERA offers a new approach to long-term hereditary angioedema (HAE) attack prevention
See what DAWNZERA has to offer
Lasting reductions in HAE attacks, with the majority of side effects being mild or moderate
A convenient, single-dose autoinjector with the longest time between doses available for HAE attack prevention*
*Available in every-4-weeks and every-8-weeks dosing.
Study Design
DAWNZERA was studied in people starting and switching HAE preventative treatments
STUDY 1 (Primary study)
Study 1 evaluated the safety and efficacy of DAWNZERA compared to placebo for 24 weeks.
45 people were given DAWNZERA every 4 weeks
23 people were given DAWNZERA every 8 weeks
22 people were given placebo†
Pooled placebo every 4 and 8 weeks.
†
STUDY 2 (Long-term safety study)
Study 2 evaluates the long-term safety and efficacy of DAWNZERA in people from Study 1 and includes a separate group of people who had switched from another HAE preventative treatment
For the long-term assessment:
69 people were given DAWNZERA every 4 weeks
14 people were given DAWNZERA every 8 weeks
For the switch assessment:
31 people switched from lanadelumab
11 people switched from berotralstat
22 people switched from C1-INH
45 people were given DAWNZERA every 4 weeks
23 people were given DAWNZERA every 8 weeks
22 people were given placebo†
Pooled placebo every 4 and 8 weeks.
†
For the long-term assessment:
69 people were given DAWNZERA every 4 weeks
14 people were given DAWNZERA every 8 weeks
For the switch assessment:
People were given DAWNZERA every 4 weeks. Results are from an interim analysis at Week 16.
31 people switched from lanadelumab
11 people switched from berotralstat
22 people switched from C1-INH
Study Results
LASTING REDUCTIONS in HAE attacks with DAWNZERA
In clinical studies, there was a steady reduction over time in the average number of HAE attacks for those who took DAWNZERA every 4 weeks.
Primary Study
81% FEWER ATTACKS
on average at 6 months vs placebo (primary endpoint)‡
Primary Study
87% FEWER ATTACKS
on average at 6 months from the 2nd dose vs placebo (secondary endpoint)‡
About 90% fewer moderate-to-severe HAE attacks, HAE attacks requiring rescue medication, and HAE attacks requiring ER visits.§
Long-Term Safety Study
94% FEWER ATTACKS
on average at 1 year vs their attack rate before beginning treatment (secondary endpoint)
About 90% fewer moderate-to-severe HAE attacks, HAE attacks requiring rescue medication, and HAE attacks requiring ER visits.§
C1-INH=C1 esterase inhibitor; ER=emergency room.
‡
Reductions in HAE attacks were measured 24 weeks after their first dose and 20 weeks after their second 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.
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 (%)
Injection-site reactions#
Upper respiratory tract infection
Urinary tract infection
Abdominal discomfort
DAWNZERA
every 4 weeks (N=45)
every 4 weeks (N=45)
11 (24)
4 (9)
4 (9)
3 (7)
DAWNZERA
every 8 weeks (N=23)
every 8 weeks (N=23)
1 (4)
2 (9)
2 (9)
0
Placebo
(N=22)
(N=22)
1 (5)
1 (5)
0
0
DAWNZERA
every 4
weeks
(N=45)
every 4
weeks
(N=45)
DAWNZERA
every 8
weeks
(N=23)
every 8
weeks
(N=23)
Placebo
(N=22)
(N=22)
Adverse reaction, n (%)
Injection-site reactions#
11 (24)
1 (4)
1 (5)
Upper respiratory tract infections
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.
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Injection-site reactions include: erythema (redness), discoloration, pain, pruritus (itching), induration (hardening or thickening of the skin), bruising, haematoma (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.
How DAWNZERA Works
Pioneering a new approach to HAE prevention
As you know, HAE is a complicated disease, and many day-to-day situations can trigger attacks, including heat, stress, and injury. However, attack triggers aren’t the underlying cause of your HAE.
DAWNZERA works differently by being the first treatment to use RNA technology for HAE prevention.
RNA technology has been used across many types of diseases for almost 30 years and works by reducing, enhancing, or modifying specific proteins.
DAWNZERA is designed to work in 3 steps:
DAWNZERA is specifically targeted to the liver.
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 to control the pathway that leads to swelling.
mRNA=messenger RNA; RNA=ribonucleic acid.