Benralizumab, sold under the brand name Fasenra, is a

monoclonal antibody A monoclonal antibody (mAb, more rarely called moAb) is an antibody produced from a cell lineage made by cloning a unique white blood cell. All subsequent antibodies derived this way trace back to a unique parent cell. Monoclonal antibodie ...

directed against the alpha chain of the interleukin-5 receptor ( CD125). It was developed by

MedImmune MedImmune, LLC was a wholly owned subsidiary of AstraZeneca before February 14, 2019, when it was announced that the MedImmune name and branding would be discontinued in favor of AstraZeneca. MedImmune was founded in 1988 as Molecular Vaccines, ...

for the treatment of

asthma Asthma is a common long-term inflammatory disease of the airways of the lungs. It is characterized by variable and recurring symptoms, reversible airflow obstruction, and easily triggered bronchospasms. Symptoms include episodes of wh ...

. It is currently marketed by

Astrazeneca AstraZeneca plc () (AZ) is a British-Swedish multinational pharmaceutical and biotechnology company with its headquarters at the Cambridge Biomedical Campus in Cambridge, UK. It has a portfolio of products for major diseases in areas includi ...

. Two phase III clinical trials of benralizumab reported meeting their primary endpoints in 2016. It was approved by the US

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...

in November 2017 for the treatment of severe eosinophilic asthma. It was granted designation as an

orphan drug An orphan drug is a medication, pharmaceutical agent that is developed to treat certain rare medical conditions. An orphan drug would not be profitable to produce without government assistance, due to the small population of patients affected by th ...

by the Food and Drug Administration for treatment of eosinophilic oesophagitis in August 2019. Common adverse effects include

injection site reaction Injection site reactions (ISRs) are reactions that occur at the site of injection of a drug. They may be mild or severe and may or may not require medical intervention. Some reactions may appear immediately after injection, and some may be delayed ...

s, which were reported in 2.2% of patients (vs. 1.9% for placebo) in clinical trials.

Clinical Trials

In November 2024, the ABRA study found that a single dose of benralizumab could be more effective when injected at the point of

exacerbation In medicine, an exacerbation is the worsening of a disease or an increase in its symptom Signs and symptoms are diagnostic indications of an illness, injury, or condition. Signs are objective and externally observable; symptoms are a person' ...

compared to currently used steroid tablets in patients at high risk of an

or chronic obstructive pulmonary disease (COPD).

References

Antiasthmatic drugs Anti-interleukin monoclonal antibodies Drugs developed by AstraZeneca Orphan drugs {{respiratory-system-drug-stub