Oral HAE treatment is now FDA-approved. On July 7, 2025, Sebetralstat (Ekterly®) became the first oral on-demand therapy for acute attacks in hereditary angioedema (HAE), marking a major shift in how this rare condition is managed.
Hereditary Angioedema (HAE) is a rare genetic disorder that causes unpredictable, recurrent episodes of swelling, often affecting the face, throat, gastrointestinal tract, and extremities. If untreated, these attacks can be life-threatening.
Until recently, on-demand treatment for HAE required injections only. While berotralstat (Orladeyo®) became the first oral medication approved for prophylaxis in 2020, acute attacks still had to be managed with injectable drugs.
That changed on July 7, 2025, when the U.S. Food and Drug Administration (FDA) approved sebetralstat (Ekterly®) as the first and only oral on-demand treatment for acute HAE attacks in patients aged 12 years and older. This milestone offers a revolutionary, needle-free option for emergency HAE management.
💊 FDA-Approved Treatments for HAE
🔹 Preventive (Prophylactic) Therapies
1. Lanadelumab (Takhzyro®)
- Form: Subcutaneous injection
- Mechanism: Monoclonal antibody inhibiting plasma kallikrein
- Approved for: Long-term prophylaxis in patients ≥2 years
- Frequency: Every 2–4 weeks
- Effectiveness: ~87% reduction in attacks
2. Berotralstat (Orladeyo®)
- Form: Once-daily oral capsule
- Mechanism: Oral kallikrein inhibitor
- Approved for: Prophylaxis in patients ≥12 years
- Significance: First oral option for long-term prevention
🔹 On-Demand (As-Needed) Therapies
Prior to 2025, all on-demand medications for HAE were injectable:
1. Icatibant (Firazyr®)
- Form: Subcutaneous injection, self-administered
- Mechanism: Bradykinin B2 receptor antagonist
- Approved for: Acute attacks in adults
- Onset: Relief typically within 1–2 hours
2. Ecallantide (Kalbitor®)
- Form: Subcutaneous injection administered by a healthcare provider
- Mechanism: Kallikrein inhibitor
- Approved for: Acute attacks in patients ≥12 years
- Caution: Requires medical supervision due to potential for anaphylaxis
🌟 Sebetralstat (Ekterly®): First Oral On-Demand Therapy
- FDA Approval Date: July 7, 2025
- Form: Oral tablet (600 mg dose; second dose may be taken ≥3 hours later)
- Indication: Treatment of acute HAE attacks in patients ≥12 years
- Mechanism: Kallikrein inhibitor to prevent bradykinin formation
- Onset of Action: ~1.6 hours to symptom relief
Why Sebetralstat is a Game Changer:
- ✅ First oral, non-injectable therapy for acute HAE attacks
- ✅ Portable and easy to administer anywhere
- ✅ Improves patient autonomy and comfort
- ✅ Reduces reliance on ER visits or injectable administration
🧠 Summary Table
| Purpose | Drug Name | Route | Age Group | Key Highlights |
| Prophylaxis | Lanadelumab | Injection | ≥2 years | Long-acting injectable; highly effective |
| Prophylaxis | Berotralstat | Oral capsule | ≥12 years | First oral daily preventive therapy |
| On-demand | Icatibant | Injection | ≥18 years | Self-injectable; fast symptom relief |
| On-demand | Ecallantide | Injection | ≥12 years | Requires medical setting due to allergy risk |
| On-demand | Sebetralstat | Oral tablet | ≥12 years | First FDA-approved oral rescue option |
🔍 Final Thoughts
The approval of sebetralstat (Ekterly®) is a landmark step in the evolution of HAE care. It not only introduces a long-awaited oral option for acute attacks but also completes the shift toward full oral management when combined with berotralstat for prevention. With more flexible, patient-friendly options, individuals with HAE can now enjoy greater control and improved quality of life.
📌 Talk to your allergist or immunologist to find the best individualized HAE treatment plan for you.
📚 References
- KalVista Pharmaceuticals. FDA Approves EKTERLY® (sebetralstat), First and Only Oral On-Demand Treatment for HAE. 2025.
- Valerieva A, et al. Advent of oral medications for the treatment of hereditary angioedema. Clin Transl Allergy. 2024 Sep;14(9):e12391. doi: 10.1002/clt2.12391.
- Pharmacy Times. Sebetralstat Becomes First and Only FDA-Approved Oral, On-Demand Treatment for HAE. 2025. Link
- European Pharmaceutical Review. FDA Approves First-of-a-Kind Oral Therapy for Rare Disease. 2025.
🛒 Recommended Resources and Tools for HAE Patients
These curated items can support patients and caregivers—providing encouragement, education, and preparedness:
A heartfelt collection of personal letters from individuals living with HAE.
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