Fasenra (benralizumab)
An approved treatment for Eosinophilic Granulomatosis with Polyangiitis.
The same compound appears under different names depending on the context. Here is how to identify Benralizumab wherever you encounter it, plus the key facts at a glance.
- Generic name
- Benralizumab
- Brand name
- Fasenra
- Development code
- MEDI-563
- Drug class
- Anti-IL-5 receptor alpha antibody
- Manufacturer
- AstraZeneca
- How it's taken
- Given as a single 30-mg subcutaneous injection every 4 weeks.
The second biologic approved for EGPA and the first to demonstrate head-to-head results against mepolizumab. For EGPA it is approved only for adults; it has not been shown to be safe and effective in children with EGPA. Benralizumab targets the IL-5 receptor on eosinophils and actively destroys them through ADCC, rather than just blocking IL-5 signaling. In the MANDARA trial, 41% of patients fully discontinued corticosteroids versus 26% on mepolizumab.
Where Benralizumab fits
Second biologic approved for EGPA (September 2024), with head-to-head data against mepolizumab showing comparable remission and superior corticosteroid-sparing effects. The single-injection convenience and lower rate of serious adverse events may make benralizumab preferred for some patients. Both IL-5-pathway biologics are now first-line options, expanding the treatment arsenal for this rare vasculitis.
How Benralizumab works
Benralizumab takes a different approach to eliminating eosinophils than mepolizumab. While mepolizumab blocks the IL-5 signal, benralizumab targets the receptor (IL-5Rα) directly on the surface of eosinophils. More importantly, benralizumab doesn't just block the receptor; it recruits the body's natural killer cells to physically destroy the eosinophils through a process called antibody-dependent cellular cytotoxicity (ADCC).
This 'kill switch' mechanism produces rapid, near-complete depletion of eosinophils from both the blood and tissues. In EGPA, this quickly halts the eosinophilic assault on blood vessels and organs, reducing inflammation and allowing tissues to heal.
The MANDARA trial compared benralizumab head-to-head against mepolizumab, the only other approved EGPA therapy. Benralizumab achieved comparable remission rates (59% vs 56%) but with a significantly better steroid-sparing effect: 41% of benralizumab patients completely discontinued oral corticosteroids versus 26% on mepolizumab. It also had fewer serious adverse events (6% vs 13%).
Mechanism: Humanized monoclonal antibody targeting the IL-5 receptor alpha subunit (IL-5Rα) on eosinophils, inducing direct eosinophil depletion through antibody-dependent cellular cytotoxicity (ADCC)
Side effects and safety
Common side effects include headache (17% in EGPA trials), sore throat, and injection site reactions (pain, redness). Hypersensitivity reactions (anaphylaxis, angioedema, urticaria) are rare but possible, usually occurring within hours of injection but sometimes delayed by days. In the MANDARA trial, benralizumab had a better safety profile than mepolizumab, with serious adverse events occurring in only 6% of patients versus 13% on mepolizumab. No new safety signals emerged beyond what was known from asthma studies. The label also warns that any parasitic worm (helminth) infection should be treated before starting Fasenra, and that Fasenra is not a rescue treatment for sudden asthma symptoms or flare-ups.
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Benralizumab
Given as a single 30-mg subcutaneous injection every 4 weeks. This is simpler than mepolizumab's three-injection regimen (three 100-mg shots per visit). The injection can be given by a healthcare provider, or with the FASENRA Pen by the patient or a caregiver after training. Corticosteroids should be tapered gradually under physician supervision after starting treatment.
Availability and cost
Only available as the brand-name product.
Help paying for Fasenra
Pick your insurance to see which help fits. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE; charity funds are the usual route there.
- Copay help
Eligible commercially insured patients may pay as little as $0 for FASENRA and its administration, up to $13,000 per calendar year. Not for government insurance.
For: private insurance · source - Infusion cost help
The savings program also covers the cost of injection administration (not office visits), within the same $13,000 yearly limit.
For: private insurance · source - Free medicine program
AstraZeneca's AZ&Me program provides FASENRA at no cost to eligible people without insurance or on Medicare who cannot afford it.
For: no insurance, Medicare · source - Insurance and case manager help
FASENRA 360 Patient Navigators answer questions about insurance coverage and out-of-pocket costs; nurse support available.
For: private insurance, Medicare, Medicaid, TRICARE, no insurance, underinsured · source
Good to know: Free drug is through AZ&Me (1-800-292-6363, azandmeapp.com); income limits apply. Medicare patients enrolled in AZ&Me must re-enroll for 2027.
- From a charity · HealthWell FoundationANCA-Associated Vasculitis and Granulomatosis with Polyangiitis fundOpen
Pays for: Copays, premiums or other treatment costs.
Clinical trial results
The Phase 3 MANDARA trial was the first head-to-head comparison of two biologics in EGPA, comparing benralizumab to mepolizumab. Remission at weeks 36-48 was achieved in 59% on benralizumab versus 56% on mepolizumab (non-inferiority demonstrated). The key differentiator was corticosteroid discontinuation: 41% of benralizumab patients fully stopped oral steroids (weeks 48-52) versus 26% on mepolizumab. Serious adverse events were reported in 6% on benralizumab and 13% on mepolizumab, though the trial was not designed to prove a safety difference.
Development history
Benralizumab was developed by MedImmune (AstraZeneca's biologics arm) and first approved for severe eosinophilic asthma in November 2017. AstraZeneca recognized its potential in EGPA and sponsored the MANDARA trial, which uniquely compared the drug head-to-head against the existing standard (mepolizumab) rather than against placebo. FDA approved benralizumab for EGPA on September 18, 2024, providing patients and clinicians with a second targeted biologic option.
Explore Eosinophilic Granulomatosis with Polyangiitis trials
Other Eosinophilic Granulomatosis with Polyangiitis treatments
Common questions about Benralizumab
▸What is Benralizumab (Fasenra)?
The second biologic approved for EGPA and the first to demonstrate head-to-head results against mepolizumab. For EGPA it is approved only for adults; it has not been shown to be safe and effective in children with EGPA. Benralizumab targets the IL-5 receptor on eosinophils and actively destroys them through ADCC, rather than just blocking IL-5 signaling. In the MANDARA trial, 41% of patients fully discontinued corticosteroids versus 26% on mepolizumab.
▸How does Benralizumab work?
Benralizumab takes a different approach to eliminating eosinophils than mepolizumab. While mepolizumab blocks the IL-5 signal, benralizumab targets the receptor (IL-5Rα) directly on the surface of eosinophils. More importantly, benralizumab doesn't just block the receptor; it recruits the body's natural killer cells to physically destroy the eosinophils through a process called antibody-dependent cellular cytotoxicity (ADCC).
This 'kill switch' mechanism produces rapid, near-complete depletion of eosinophils from both the blood and tissues. In EGPA, this quickly halts the eosinophilic assault on blood vessels and organs, reducing inflammation and allowing tissues to heal.
The MANDARA trial compared benralizumab head-to-head against mepolizumab, the only other approved EGPA therapy. Benralizumab achieved comparable remission rates (59% vs 56%) but with a significantly better steroid-sparing effect: 41% of benralizumab patients completely discontinued oral corticosteroids versus 26% on mepolizumab. It also had fewer serious adverse events (6% vs 13%).
▸What are the side effects of Benralizumab?
Common side effects include headache (17% in EGPA trials), sore throat, and injection site reactions (pain, redness). Hypersensitivity reactions (anaphylaxis, angioedema, urticaria) are rare but possible, usually occurring within hours of injection but sometimes delayed by days. In the MANDARA trial, benralizumab had a better safety profile than mepolizumab, with serious adverse events occurring in only 6% of patients versus 13% on mepolizumab. No new safety signals emerged beyond what was known from asthma studies. The label also warns that any parasitic worm (helminth) infection should be treated before starting Fasenra, and that Fasenra is not a rescue treatment for sudden asthma symptoms or flare-ups.
▸How is Benralizumab taken?
Given as a single 30-mg subcutaneous injection every 4 weeks. This is simpler than mepolizumab's three-injection regimen (three 100-mg shots per visit). The injection can be given by a healthcare provider, or with the FASENRA Pen by the patient or a caregiver after training. Corticosteroids should be tapered gradually under physician supervision after starting treatment.
▸Is Benralizumab FDA approved?
Yes, Benralizumab (Fasenra) is FDA approved (2024) for the treatment of Eosinophilic Granulomatosis with Polyangiitis.
▸How does Fasenra compare to Nucala for EGPA?
In the head-to-head MANDARA trial, benralizumab (Fasenra) achieved comparable remission rates to mepolizumab (Nucala) but with better steroid-sparing results: 41% fully stopped steroids on Fasenra versus 26% on Nucala. Fasenra also had fewer serious side effects.
▸What is the advantage of benralizumab over mepolizumab?
Benralizumab directly destroys eosinophils through ADCC rather than just blocking their growth signal. It also requires only one injection per visit versus three for mepolizumab, and showed a superior safety profile in the MANDARA trial.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- AstraZeneca · September 18, 2024. Fasenra approved in the US for eosinophilic granulomatosis with polyangiitis. https://www.astrazeneca.com/media-centre/press-releases/2024/fasenra-approved-in-the-us-for-eosinophilic-granulomatosis-with-polyangiitis.html
- New England Journal of Medicine. Benralizumab versus Mepolizumab for Eosinophilic Granulomatosis with Polyangiitis. https://www.nejm.org/doi/full/10.1056/NEJMoa2311155
- AstraZeneca. Fasenra (benralizumab) for EGPA. https://www.fasenra.com/egpa