FASENRA STUDIES
FASENRA Pivotal Phase 3 Trial
In the MANDARA pivotal trial (52 weeks), FASENRA demonstrated noninferiority to mepolizumab for the primary endpoint of remission and the components of remission. 59% remission at Weeks 36 and 48 (n=41) with FASENRA and 57% with mepolizumab (n=40).1,2
- MANDARA was a 52-week, randomized, double-blind, active-controlled, head-to-head noninferiority trial comparing the efficacy and safety of FASENRA to mepolizumab in adult patients with relapsing or refractory EGPA1-4
- At the end of the double-blind period, 128 patients entered the open-label extension (OLE) for at least 1 year. Patients either continued on FASENRA or switched from mepolizumab to FASENRA1-4
Key OLE Limitations: The OLE period only included FASENRA treatment arms. Treatment with mepolizumab was not assessed during the OLE period. The impact of remission and steroid reduction compared to FASENRA at 2 years remains unknown.4
Safety Data in MANDARA Noninferiority Trial
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MANDARA is a head-to-head noninferiority trial with an open-label extension comparing the efficacy and safety of FASENRA to mepolizumab.1-4
Click here for Study Design. In MANDARA, the primary endpoint was achieved, with FASENRA demonstrating noninferiority to mepolizumab in remission.1-4
FASENRA demonstrated noninferiority to mepolizumab for the primary endpoint of remission and the components of remission. 59% remission at Weeks 36 and 48 (n=41) with FASENRA, and 57% with mepolizumab (n=40).1-4
In the EGPA study, the incidence of adverse reactions was consistent with those reported in asthma, with the exception of headache, which occurred in 17% of FASENRA-treated patients with EGPA. No new adverse reactions were identified.1
MANDARA Adverse Events (≥5%): Pivotal Study2
| FASENRA (n=70) |
Mepolizumab (n=70) |
|
|---|---|---|
| COVID-19 | 21% | 27% |
| Headache | 17% | 16% |
| Arthralgia | 17% | 11% |
| Nasopharyngitis | 9% | 14% |
| Sinusitis | 7% | 11% |
| FASENRA (n=70) |
|
|---|---|
| COVID-19 | 21% |
| Headache | 17% |
| Arthralgia | 17% |
| Nasopharyngitis | 9% |
| Sinusitis | 7% |
| Mepolizumab (n=70) |
|
|---|---|
| COVID-19 | 27% |
| Headache | 16% |
| Arthralgia | 11% |
| Nasopharyngitis | 14% |
| Sinusitis | 11% |
No new safety signals were identified in the open-label extension at 2 years.4
- No patients taking FASENRA had adverse events leading to treatment discontinuation.2 Two patients who received mepolizumab had a serious adverse event (prostate cancer) that was not considered related to treatment but did result in discontinuation of participation in the trial2
OLE period analysis data2,4
- Adverse events seen during the open-label extension were comparable to those in the double-blind phase2,4
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Submit requestPivotal Study Design
MANDARA Trial1-4
MANDARA (52 weeks) is a Phase 3, multicenter, double-blind, randomized, active-controlled, head-to-head noninferiority trial evaluating the efficacy and safety of FASENRA 30 mg SC compared to mepolizumab 300 mg SC every 4 weeks. A total of 140 patients aged 18 years and older with an EGPA diagnosis and a history of relapsing or refractory disease who were receiving standard care underwent randomization in a 1:1 ratio to receive FASENRA or mepolizumab.1-4
The primary endpoint was remission (BVAS=0 and OCS ≤4 mg per day) at Weeks 36 and 48. Secondary endpoints included total accrued duration of remission, remission within the first 24 weeks and maintenance of remission to Week 52, the time from randomization to first relapse, major relapse, the frequency of relapse during the double-blind period, and the average daily oral glucocorticoid dose during Weeks 48 through 52.1-3
BVAS, Birmingham Vasculitis Activity Score; EGPA, eosinophilic granulomatosis with polyangiitis; OCS, oral corticosteroid; SC, subcutaneous.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Known hypersensitivity to benralizumab or excipients.
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions
Hypersensitivity reactions (eg, anaphylaxis, angioedema, urticaria, rash) have occurred after administration of FASENRA. These reactions generally occur within hours of administration, but in some instances have a delayed onset (ie, days). Discontinue in the event of a hypersensitivity reaction.
Acute Asthma Symptoms or Deteriorating Disease
FASENRA should not be used to treat acute asthma symptoms, acute exacerbations, or acute bronchospasm.
Reduction of Corticosteroid Dosage
Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with FASENRA. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.
Parasitic (Helminth) Infection
It is unknown if FASENRA will influence a patient's response against helminth infections. Treat patients with pre-existing helminth infections before initiating therapy with FASENRA. If patients become infected while receiving FASENRA and do not respond to anti-helminth treatment, discontinue FASENRA until infection resolves.
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥ 5%):
- Asthma: headache, pharyngitis
- EGPA: headache
- HES: headache, hypersensitivity reactions, influenza-like illness
Injection site reactions (eg, pain, erythema, pruritus, papule) occurred at a rate of 2.2% in patients treated with FASENRA compared with 1.9% in patients treated with placebo in asthma exacerbation studies.
USE IN SPECIFIC POPULATIONS
The data on pregnancy exposure from the clinical trials are insufficient to inform on drug-associated risk. Monoclonal antibodies such as benralizumab are transported across the placenta during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy.
INDICATIONS
FASENRA is indicated for:
- the add-on maintenance treatment of patients with severe asthma aged 6 years and older and with an eosinophilic phenotype. FASENRA is not indicated for the relief of acute bronchospasm or status asthmaticus
- the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA)
- the treatment of adult and adolescent patients aged 12 years and older with hypereosinophilic syndrome (HES) without an identifiable non-hematologic secondary cause
Please read full Prescribing Information, including Patient Information.
References:
1. FASENRA® (benralizumab) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; September 2026. 2. Wechsler ME, Nair P, Terrier B, et al. Benralizumab versus mepolizumab for eosinophilic granulomatosis with polyangiitis. N Engl J Med. 2024;390(10):911-921. 3. Wechsler ME, Nair P, Terrier B, et al. Benralizumab versus mepolizumab for eosinophilic granulomatosis with polyangiitis. N Engl J Med. 2024;390(10)(suppl):1-46. 4. Merkel PA, Nair PK, Khalidi N, et al. Two-year efficacy and safety of anti-interleukin-5/receptor therapy for eosinophilic granulomatosis with polyangiitis. Ann Rheum Dis. 2025;84(11):1888-1899.
