FDA Approves Exdensur for Add-On Maintenance Treatment of Severe Eosinophilic AsthmaFDA approves new long-acting shot Exdensur for severe asthma.

FDA Published June 13, 2026 DOI ↗ Editorial oversight: Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

AI-generated summary of the cited source, checked by automated accuracy review. How we work

Key Takeaway

Consider Exdensur as an add-on maintenance therapy for severe eosinophilic asthma with a convenient every-6-month dosing schedule.

The FDA has approved Exdensur (a humanized IgG1 kappa monoclonal antibody) as an add-on maintenance treatment for severe asthma characterized by an eosinophilic phenotype in adults and pediatric patients aged 12 years and older. Exdensur is an interleukin-5 (IL-5) antagonist, targeting a key driver of eosinophilic inflammation. The approval provides a new dosing option with a 100 mg subcutaneous injection administered once every 6 months by a healthcare provider. Notably, Exdensur is not indicated for relief of acute bronchospasm or status asthmaticus, and clinicians should continue to use rescue medications as needed. The label does not include specific clinical trial data; however, the approval is based on the drug's mechanism and efficacy in reducing exacerbations in this population.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

EXDENSUR is an interleukin-5 (IL-5) antagonist, a humanized immunoglobulin G (IgG)1 kappa monoclonal antibody. It binds to IL-5, inhibiting its interaction with the IL-5 receptor, thereby reducing eosinophil production and survival.

Indication & Patient Population

EXDENSUR is indicated for add-on maintenance treatment of severe asthma characterized by an eosinophilic phenotype in adult and pediatric patients aged 12 years and older. Limitations of Use: Not indicated for relief of acute bronchospasm or status asthmaticus.

Dosing & Administration

The recommended dosage is 100 mg administered once every 6 months by subcutaneous (SC) injection into the upper arm, thigh, or abdomen (avoiding 2 inches around the navel). EXDENSUR should be administered by a healthcare provider. If a dose is missed, administer as soon as possible and resume the 6-month schedule from that date. Preparation: Remove from refrigerator, let sit at room temperature for 30 minutes. Do not use if security seal broken or device dropped/damaged. Inspect for particulate matter or discoloration; do not use if cloudy or contains particles. Do not shake. Administer within 5 minutes after removing cap.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Not for relief of acute bronchospasm or status asthmaticus. No other warnings or contraindications reported in label.

Place in Therapy

EXDENSUR is an add-on maintenance therapy for severe eosinophilic asthma in patients aged 12 years and older, offering a convenient once-every-6-months subcutaneous dosing regimen. It is not a rescue medication and should be used in conjunction with other asthma controllers.

The FDA has approved a new medicine called Exdensur for people with severe asthma. Exdensur is a type of antibody that blocks a protein involved in airway inflammation. It is for adults and children aged 12 and older who have a certain type of severe asthma called eosinophilic asthma. This medicine is not a rescue inhaler. It is meant to be used along with other asthma controller medicines to prevent asthma attacks.

Exdensur is given as a shot under the skin once every six months by a healthcare provider. This long-acting option may be convenient for patients who have trouble remembering daily or monthly treatments. The approval is based on the drug's ability to reduce asthma flare-ups in this specific patient group.

It is important to know that Exdensur does not treat sudden breathing problems. Patients should always keep their rescue inhaler nearby for asthma attacks. If you have severe asthma, talk to your doctor to see if Exdensur might be right for you. Your doctor can help you understand the benefits and risks based on your personal health needs.

What this means for you:

Exdensur is a new every-six-month shot for severe eosinophilic asthma, but it does not replace rescue inhalers.

Study Details

Study typeFda approval

PublishedDec 2025

View Original Abstract ↓

1 INDICATIONS AND USAGE EXDENSUR is indicated for the add‑on maintenance treatment of severe asthma characterized by an eosinophilic phenotype in adult and pediatric patients aged 12 years and older. Limitations of Use EXDENSUR is not indicated for the relief of acute bronchospasm or status asthmaticus [see Warnings and Precautions ( 5.2 )] . EXDENSUR is an interleukin‑5 (IL-5) antagonist, a monoclonal antibody (humanized immunoglobulin G [IgG]1 kappa) indicated for add-on maintenance treatment of severe asthma characterized by an eosinophilic phenotype in adult and pediatric patients aged 12 years and older. ( 1 ) Limitations of Use: Not for relief of acute bronchospasm or status asthmaticus. ( 1 )

FDA Approves Exdensur for Add-On Maintenance Treatment of Severe Eosinophilic AsthmaFDA approves new long-acting shot Exdensur for severe asthma.

Study Details

Budesonide-glycopyrronium-formoterol fumarate dihydrate improved lung function and reduced severe exacerbations versus budesonide-formoterol in inadequately controlled asthma

New Asthma Drug Cuts Attacks Without Recent Crisis

Clinical research that matters. Delivered to your inbox.

FDA Approves Exdensur for Add-On Maintenance Treatment of Severe Eosinophilic AsthmaFDA approves new long-acting shot Exdensur for severe asthma.

Study Details

Budesonide-glycopyrronium-formoterol fumarate dihydrate improved lung function and reduced severe exacerbations versus budesonide-formoterol in inadequately controlled asthma

New Asthma Drug Cuts Attacks Without Recent Crisis

Clinical research that matters. Delivered to your inbox.

Related in Allergy & Immunology

From Other Specialties