MOA

FASENRA has a unique mechanism of action.1,2

FASENRA is the only anti-eosinophil that binds directly at the surface of the eosinophil.1

01

Mechanism
of Action

FASENRA directly targets and nearly depletes blood eosinophils, regardless of activation pathway*1-3

*The pharmacodynamic response (blood eosinophil depletion) following repeat subcutaneous (SC) dosing was evaluated in asthma patients in a 12-week phase 2 trial. Patients received 1 of 3 doses of benralizumab [25 mg (n=6), 100 mg (n=6) or 200 mg (n=6) SC] or placebo (n=6) every 4 weeks for a total of 3 doses. Twenty-four hours post dosing, all benralizumab dosage groups demonstrated complete or near complete depletion of median blood eosinophil levels, which was maintained throughout the dosing period.1-3

Anti-Eosinophil Monoclonal Antibody Anti-Eosinophil Monoclonal Antibody FASENRA

FASENRA accomplishes direct and rapid depletion of eosinophils in 2 steps.1

FASENRA Binds Directly to the IL-5 Receptor Alpha on Eosinophils FASENRA Binds Directly to the IL-5 Receptor Alpha on Eosinophils EOSINOPHIL IL-5 RECEPTOR ALPHA

STEP 1

FASENRA is the first and only anti-eosinophil monoclonal antibody that binds directly to the IL-5 receptor alpha on eosinophils.1

FASENRA Attracts Natural Killer Cells to Induce Apoptosis of Eosinophils FASENRA Attracts Natural Killer Cells to Induce Apoptosis of Eosinophils NATURAL KILLER CELL

STEP 2

FASENRA uniquely attracts natural killer cells to induce apoptosis of eosinophils, without the release of inflammatory mediators.1,2

The mechanism of action of benralizumab in asthma has not been definitively established.1

Immerse yourself in the mechanism of action of FASENRA.

02

Rapid near complete depletion of blood eosinophils with FASENRA†1-3

The pharmacodynamic response (blood eosinophil depletion) following repeat subcutaneous (SC) dosing was evaluated in asthma patients in a 12-week phase 2 trial. Patients received 1 of 3 doses of benralizumab [25 mg (n=6), 100 mg (n=6) or 200 mg (n=6) SC] or placebo (n=6) every 4 weeks for a total of 3 doses. Twenty-four hours post dosing, all benralizumab dosage groups demonstrated complete or near complete depletion of median blood eosinophil levels, which was maintained throughout the dosing period.*1-3

At baseline of the BORA trial, in patients with baseline blood eosinophil count ≥300 cells/μL in SIROCCO and CALIMA who continued on FASENRA every 8 weeks (n=339), the median EOS level was 0 cells/μL, which was maintained through Week 56.4,5

§The effect of the treatment on sputum eosinophils was evaluated in a sub-study of ZONDA. Patients were randomized to receive benralizumab 30 mg SC every 4 weeks (Q4W), every 8 weeks (Q8W; first 3 doses Q4W) or placebo Q4W. In a combined analysis of the benralizumab 30 mg Q4W and Q8W groups, median sputum eosinophils were depleted for patients treated with benralizumab from 4.90% (n=18) at baseline to 0.0% (n=16) at Week 12, and 0.15% (n=8) at Week 28. For patients who received placebo, median sputum eosinophil counts increased from 4.90% (n=8) at baseline to 17.55% (n=4) at Week 12 and 12.15% (n=4) at Week 28. Results are descriptive only.6

FASENRA is the first and only anti-eosinophil biologic that provides near complete depletion of blood eosinophils in 24 hours†1-3

The relationship between the pharmacologic properties and clinical efficacy has not been established.



In BORA (phase 3 safety extension trial of SIROCCO and CALIMA), median blood eosinophils started at 0 and remained at 0.0 cells/μL in Year 2 of treatment‡4,5

Patients who received FASENRA in ZONDA (Trial 3) had decreased median sputum eosinophils from 4.90% (n=18) at baseline to 0.15% (n=8) at treatment end.§6

 

In ZONDA, FASENRA and placebo were administered in addition to daily OCS (7.5 to 40 mg) + SOC, which was defined as high-dose ICS/LABA with or without other controllers.1 In BORA, patients from SIROCCO and CALIMA (Trials 1 and 2) were randomized to continue FASENRA administered at the same dose or re-randomized from placebo to 1 of 2 doses of FASENRA.4

 

ICS=inhaled corticosteroids; LABA=long-acting β2-agonists; OCS=oral corticosteroids; SOC=standard of care.

 

FOOTNOTES

The pharmacodynamic response (blood eosinophil depletion) following repeat subcutaneous (SC) dosing was evaluated in asthma patients in a 12-week phase 2 trial. Patients received 1 of 3 doses of benralizumab [25 mg (n=6), 100 mg (n=6) or 200 mg (n=6) SC] or placebo (n=6) every 4 weeks for a total of 3 doses. Twenty-four hours post dosing, all benralizumab dosage groups demonstrated complete or near complete depletion of median blood eosinophil levels, which was maintained throughout the dosing period.*1-3

At baseline of the BORA trial, in patients with baseline blood eosinophil count ≥300 cells/μL in SIROCCO and CALIMA who continued on FASENRA every 8 weeks (n=339), the median EOS level was 0 cells/μL, which was maintained through Week 56.4,5

§The effect of the treatment on sputum eosinophils was evaluated in a sub-study of ZONDA. Patients were randomized to receive benralizumab 30 mg SC every 4 weeks (Q4W), every 8 weeks (Q8W; first 3 doses Q4W) or placebo Q4W. In a combined analysis of the benralizumab 30 mg Q4W and Q8W groups, median sputum eosinophils were depleted for patients treated with benralizumab from 4.90% (n=18) at baseline to 0.0% (n=16) at Week 12, and 0.15% (n=8) at Week 28. For patients who received placebo, median sputum eosinophil counts increased from 4.90% (n=8) at baseline to 17.55% (n=4) at Week 12 and 12.15% (n=4) at Week 28. Results are descriptive only.6

Power to Prevent Exacerbations

Learn more about the efficacy of FASENRA in relation to exacerbation rate reduction and lung function data.

Protection From Systemic Corticosteroid Exposure

Learn more about how FASENRA can provide protection from exacerbations requiring steroids and dependence on OCS.

Study
Designs

See full study descriptions for SIROCCO, CALIMA, BORA, ANDHI, and more.

IMPORTANT SAFETY INFORMATION