Exdensur

Exdensur (depemokimab) is a new, long-acting biologic medicine used to treat severe asthma with an eosinophilic phenotype in people aged 12 and older.

Exdensur is given twice a year as a subcutaneous injection (an injection under the skin) using a pre-filled pen or syringe.

Exdensur works by targeting and blocking IL-5, a key protein that drives type 2 inflammation in asthma. By inhibiting IL-5 signaling, Exdensur reduces eosinophil production and survival, which helps lower inflammation and reduce asthma symptoms. Exdensur is called an interleukin-5 (IL-5) antagonist.

Exdensur is used for severe asthma of the eosinophilic phenotype in patients 12 years and older, as an add-on maintenance treatment. FDA approval was granted on December 16, 2025.

It should not be used for relief of acute bronchospasm or acute asthma treatment.

In the phase III SWIFT-1 (NCT04719832) and SWIFT-2 (NCT04718103) trials, Exdensur significantly reduced asthma attacks over 52 weeks compared with placebo when given twice a year in addition to standard care.

Exdensur patients' annualized asthma attacks dropped by 58% in SWIFT-1 and by 48% in SWIFT-2, and a pooled analysis showed a 72% reduction in asthma exacerbations requiring hospitalization or emergency department visits.

Hypersensitivity reactions, including anaphylaxis, may occur after administration of Exdensur. If a hypersensitivity reaction occurs, discontinue Exdensure and start appropriate therapy.

Do not abruptly discontinue systemic or inhaled corticosteroids upon initiation of therapy with Exdensur. Reduce corticosteroid dose gradually, if appropriate.

Pre-existing worm (helminth) infections should be treated before starting Exdensur therapy. If patients become infected while receiving treatment with Endensur and do not respond to anti-helminth treatment, then Exdensur should be discontinued until the parasitic infection resolves.

Before using this medicine, tell your healthcare provider about all of your medical conditions, including if you:

• are taking systemic or inhaled corticosteroid medicines. Do not change or stop taking your corticosteroid medicines unless instructed by your healthcare provider. This may cause other symptoms that were controlled by the corticosteroid medicine to come back.
• have a parasitic worm (helminth) infection.

Pregnancy

Tell your healthcare professional if you are pregnant or plan to become pregnant. Babies exposed to Exdensur before birth may have higher and longer-lasting levels of the medicine in their bodies. It is not known if Exdensur may harm your unborn baby. If you become pregnant while taking this medicine, contact GlaxoSmithKline at 1-888-825-5249.

Breastfeeding

Tell your healthcare professional are breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you will use Exdensur and breastfeed. You should not use Exdensur and breastfeed without talking with your healthcare provider first.

The most common Endensur side effects are:

• upper respiratory tract infection (common cold, sinus infection)
• sneezing, nasal congestion, runny nose, and nasal itching (allergic rhinitis)
• flu or flu-like symptoms
• joint pain (arthralgia)
• sore throat (pharyngitis)

Serious side effects

Serious allergic (hypersensitivity) reactions, including anaphylaxis, can occur after your injection. Contact your healthcare provider or get emergency help right away if you have any of the following symptoms of an allergic reaction:

• swelling of your face, mouth, and tongue
• breathing problems
• fainting, dizziness, feeling lightheaded (low blood pressure)
• rash
• hives

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Exdensur is given as an injection under the skin (subcutaneous injection) every 6 months by your healthcare provider. The injection site can be the upper arm, thigh, or abdomen, avoiding 2 inches (5 cm) around the navel.

If you miss a dose of Exdensur, contact your healthcare provider to get your next dose as soon as you can.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Do not change or stop taking your other medicines unless instructed to do so by your healthcare provider. Not all possible drug interactions are listed here

• Store refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light.
• Do not freeze.
• Do not shake.
• Avoid exposure to heat.
• The prefilled pen and prefilled syringe can be removed from the refrigerator and kept in the unopened carton, protected from light, for up to 7 days at room temperature up to 86°F (30°C).
• Discard if left out of the refrigerator for more than 7 days.
• The prefilled pen or prefilled syringe must be administered within 8 hours once removed from the carton. Discard if not administered within 8 hours

Active ingredients: depemokimab-ulaa

Inactive ingredients: arginine HCl, edetate disodium, histidine, L-histidine HCl monohydrate, polysorbate 80, trehalose, Water for Injection

The pens and syringes are not made with natural rubber latex.

Exdensur Manufacturer is GlaxoSmithKline LLC, Philadelphia, PA 19104, U.S. License No. 1727

Distributed by GlaxoSmithKline, Durham, NC 27701