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MAY 14 2026
APPROVED · 138 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 high levels of white blood cells called eosinophils persist in the blood for months, which can damage the heart, nerves, or bone marrow. Fasenra (benralizumab) is an antibody that binds to a receptor on eosinophils, prompting the body's immune system to rapidly remove these cells. By depleting eosinophils, this drug may reduce the tissue damage that drives the serious complications of the disease.

Pivotal trial

ROSY-F Phase 3 recruiting NCT07444567

The rationale of the roll-over study (ROSY) is to provide continuous access to study treatment for participants who have completed or exited a parent study and are deemed appropriate for continued benralizumab treatment, as judged by the Investigator, while monitoring long-term safety and tolerability of benralizumab.

Source: ClinicalTrials.gov

Also in development