The Front Room — a clinical regulatory commons
RSS
← Back to The Docket
MAY 14 2026
APPROVED · 20 DAYS AGO

AstraZeneca Fasenra (benralizumab) $AZN

for Hypereosinophilic Syndrome

BLA

FDA approved AstraZeneca's Fasenra for adult and pediatric patients aged 12+ with hypereosinophilic syndrome without an identifiable non-hematologic cause.

About

Hypereosinophilic syndrome is a condition where the body produces abnormally high levels of eosinophils, a type of white blood cell, which can damage the heart, nervous system, or bone marrow. Fasenra is an antibody that targets and eliminates eosinophils by binding to a specific receptor on their surface. By reducing eosinophil levels, Fasenra may help prevent the organ damage caused by their overproduction.

Pivotal trial

NATRON Phase 3 active not recruiting NCT04191304

This is a multicentre, randomised, double-blind (DB), parallel-group, placebo-controlled, 24-week Phase III study to compare the efficacy and safety of benralizumab versus placebo administered by SC injection Q4W in patients with hypereosinophilic syndrome (HES). This study comprises 2 distinct periods (together defined as the 'main study'): A 24-week, DB treatment period, during which patients will be randomised to receive either benralizumab or placebo, in addition to their prior stable HES...

Source: ClinicalTrials.gov

Also in development