The only HAE prophylactic with prospective switch results1

Pivotal study: The safety and efficacy of DAWNZERA were evaluated in the randomized, placebo-controlled OASIS-HAE trial. At Week 24, DAWNZERA every 4 weeks (n=45) demonstrated a significant reduction in the mean monthly attack rate vs placebo (n=22), (LSM 0.44 vs 2.26; primary endpoint, P<0.001).2

In the open-label switch cohort after 1 year (view study design below):

Secondary endpoint: reductions in mean monthly HAE attack
rate (investigator-confirmed) after switching to DAWNZERA every 4 weeks.¹
A graph showing reductions in mean monthly HAE attack rate (investigator-confirmed) after switching to DAWNZERA every 4 weeks. A graph showing reductions in mean monthly HAE attack rate (investigator-confirmed) after switching to DAWNZERA every 4 weeks.

Switching to DAWNZERA Q4W reduced mean HAE attack rate by 68% from prior treatment1*

  • These are not head-to-head data. Findings are from an open-label, uncontrolled safety study in patients who wanted to switch to DAWNZERA and were not powered for any comparisons between prior treatment groups; thus, these observations cannot be generalized to other patients on prior long-term prophylactic treatments
  • The majority of adverse events were mild to moderate and consistent with the placebo-controlled study1
Secondary endpoint: mean monthly HAE attack rate (investigator-confirmed) from baseline after switching to DAWNZERA Q4W¹*
Prior LTP
  • Lanadelumab
  • Berotralstat
  • C1-INH
A graph showing reductions in mean monthly HAE attack rate (investigator-confirmed) after switching to DAWNZERA Q4W. A graph showing reductions in mean monthly HAE attack rate (investigator-confirmed) after switching to DAWNZERA Q4W.

Secondary endpoint: mean monthly HAE attack rate (investigator-confirmed) from baseline after switching to DAWNZERA Q4W¹*

Prior LTP
  • Lanadelumab
  • Berotralstat
  • C1-INH
A graph showing reductions in mean monthly HAE attack rate (investigator-confirmed) after switching to DAWNZERA Q4W.

Patients successfully switched to DAWNZERA with no mean loss of efficacy and no new safety signals1,3

  • These are not head-to-head data. Findings are from an open-label, uncontrolled safety study in patients who wanted to switch to DAWNZERA and were not powered for any comparisons between prior treatment groups; thus, these observations cannot be generalized to other patients on prior long-term prophylactic treatments
  • The majority of adverse events were mild to moderate and consistent with the placebo-controlled study1

*Baseline monthly HAE attack rate established in the 10-week screening period.1

DAWNZERA is the only LTP with an evidence-based switch protocol3

Learn about the switch protocol

At 16 weeks, a majority of patients reported they preferred DAWNZERA3

In an interim analysis at Week 16 of the switch study,
exploratory endpoint: patient-reported preference (n=55)

84% of patients reported they preferred DAWNZERA.

PREFERRED DAWNZERA

of patients surveyed at Week 16 who switched PREFERRED DAWNZERA Q4W, most saying it worked better to control their HAE

Reasons patients chose for preferring DAWNZERA Q4W†:

  • 63% chose “it works better to control my HAE”
  • 65% chose “less time to administer”
  • 50% chose “less injection-site pain or reaction”
  • These are not head-to-head data. Findings are from an open-label, uncontrolled safety study in patients who wanted to switch to DAWNZERA and were not powered for any comparisons between prior treatment groups; thus, these observations cannot be generalized to other patients on prior long-term prophylactic treatments
  • The majority of adverse events were mild to moderate and consistent with the placebo-controlled study1

 

C1-INH=C1-inhibitor; HAE=hereditary angioedema; LSM=least-squares mean; LTP=long-term prophylactic treatment; Q4W=every 4 weeks.

†More than 1 reason was permitted.3

See other areas to explore for DAWNZERA:

View patient-reported outcomes View dosing information

Study design: Pivotal study (OASIS-HAE) and open-label extension study (OASISplus)

Study design diagram showing the OASIS-HAE placebo-controlled trial and OASISplus open-label extension rollover and switch cohorts. Study design diagram showing the OASIS-HAE placebo-controlled trial and OASISplus open-label extension rollover and switch cohorts.

OASIS-HAE: Phase 3, randomized, double-blind, placebo-controlled 24-week trial of patients aged ≥12 years with HAE type 1 or 2 (N=90)2,5

  • At baseline, 69% of patients had >2 monthly attacks2
  • Enrolled patients had to have at least 2 investigator-confirmed attacks during the 8-week run-in period2

OASISplus: Ongoing, open-label, long-term safety (primary endpoint) and efficacy (secondary endpoint) study of patients with HAE type 1 or 2 (N=147)1,4

  • Open-label extension cohort: After 24 weeks, patients in OASIS-HAE were able to continue into the OASISplus open-label extension study†
  • Open-label switch cohort: An independent cohort of patients enrolled and had to be on a stable dose of prophylactic therapy for ≥12 weeks. Patients started taking DAWNZERA every 4 weeks on study Day 1, following the 14-day switch protocol

92% of eligible patients opted to continue in the open-label extension study4†

C1-INH=C1-inhibitor; HAE=hereditary angioedema; Q4W=every 4 weeks; Q8W=every 8 weeks.

*Pooled placebo every 4 and 8 weeks.2

†83 of 90 eligible patients rolled over into the open-label extension study.4

IMPORTANT SAFETY INFORMATION & INDICATION

CONTRAINDICATIONS

DAWNZERA is contraindicated in patients with a history of serious hypersensitivity reactions, including anaphylaxis, to donidalorsen or any of the excipients in DAWNZERA.

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions

Hypersensitivity reactions, including anaphylaxis, have been reported in patients treated with DAWNZERA. If signs and symptoms of serious hypersensitivity reactions occur, discontinue DAWNZERA and institute appropriate therapy.

ADVERSE REACTIONS

Most common adverse reactions (incidence ≥ 5%) are injection site reactions, upper respiratory tract infection, urinary tract infection, and abdominal discomfort.

INDICATION

DAWNZERA (donidalorsen) is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older.

Please see full Prescribing Information for DAWNZERA.

References: 1. Riedl MA, Bernstein JA, Jacobs JS, et al. Switching long-term prophylaxis to donidalorsen for hereditary angioedema: 1-year OASISplus results. Allergy. 2026;1-10. doi:10.1111/all.70294 2. DAWNZERA. Prescribing information. Ionis Pharmaceuticals. 3. Riedl MA, Bernstein JA, Jacobs JS, et al. Donidalorsen treatment of hereditary angioedema in patients previously on long-term prophylaxis. J Allergy Clin Immunol Pract. 2025;13(9):2381-2389.e3. doi:10.1016/j.jaip.2025.06.018 4. Lumry WR, Tachdjian R, Craig T, et al. Donidalorsen for long-term prophylaxis of hereditary angioedema attacks: results from the OASISplus open-label extension cohort at year 1.  J Asthma Allergy. 2026;19:592079. doi:10.2147/JAA.S592079 5. Riedl MA, Tachdjian R, Lumry WR, et al. Efficacy and safety of donidalorsen for hereditary angioedema. N Engl J Med. 2024;391(1):21-31. doi:10.1056/NEJMoa2402478