ULTRA-LONG-ACTING DESIGN

Discover the science behind EXDENSUR

Designed to be ultra-long-acting

EXDENSUR by design

For illustrative purposes only.

The mechanism of action of EXDENSUR has not been definitively established.

  • *

    Depemokimab-ulaa binds to IL-5 with a dissociation constant of 10.5 pM.1,2

  • †

    Depemokimab-ulaa inhibits the bioactivity of IL-5 with picomolar concentration of IC50 4pM.1,2

  • ‡

    Depemokimab-ulaa contains a triple amino acid substitution (YTE) in the fragment crystallizable (Fc) region which increases binding to the neonatal Fc receptor.

IC50=half maximal inhibitory concentration; IL-5=interleukin-5; pM=picomolar.

Sustained suppression of a key driver of type 2 inflammation*

EXDENSUR reduced blood eosinophil counts vs baseline at Week 2 by 80% (first measure)† and sustained this reduction through Week 52 at 82%.3‡

SWIFT-1/2 pooled analysis: Eosinophil reduction maintained throughout treatment period3

Eosinophil data over 52 weeks

Results are descriptive. The clinical significance of this pharmacodynamic data is unknown.

  • *

    Multiple cell types and mediators are involved in inflammation.

  • †

    Blood eosinophil counts at Week 2: EXDENSUR 63 cells/µL, placebo 326 cells/µL.

  • ‡

    Blood eosinophil reduction data are based on geometric mean.

View SWIFT-1 and SWIFT-2—phase 3, 52-week studies of the efficacy and safety of EXDENSUR. See study design and description.

SOC=standard of care.

More to explore:

Dosing & Administration

In-office administration allows you to confidently deliver 6 months of therapy with every subcutaneous (SC) injection.

LEARN ABOUT DOSING

Efficacy data

Explore results from phase 3 clinical trials.

VIEW DATA

Indication & Safety Info

Indication

Important Safety Information

Indication

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. EXDENSUR is not indicated for the relief of acute bronchospasm or status asthmaticus.

Important Safety Information

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions
Hypersensitivity reactions, including anaphylaxis, can occur following administration of EXDENSUR. If a hypersensitivity reaction occurs, discontinue EXDENSUR and initiate appropriate therapy.

Acute Asthma Symptoms or Deteriorating Disease
EXDENSUR should not be used to treat acute asthma symptoms or acute exacerbations.

Risk Associated with Abrupt Reduction of Corticosteroid Dosage
Upon initiation of EXDENSUR therapy, do not abruptly discontinue systemic or inhaled corticosteroids. Reductions in corticosteroid dose, if appropriate, should be gradual and under the supervision of a healthcare provider. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.

Parasitic (Helminth) Infection
Patients with pre-existing helminth infections should be treated for their infection prior to initiation of EXDENSUR therapy. If patients become infected while receiving EXDENSUR and do not respond to anti-helminth treatment, discontinue EXDENSUR until the infection resolves.

ADVERSE REACTIONS

In patients receiving EXDENSUR, the most common adverse reactions (≥4%) were upper respiratory tract infection, allergic rhinitis, influenza, arthralgia, and pharyngitis. Injection site reactions have also occurred. 

USE IN SPECIFIC POPULATIONS

The data in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Transport of endogenous IgG antibodies and monoclonal antibodies, such as depemokimab-ulaa, across the placenta increases as pregnancy progresses and peaks during the third trimester.

EXDENSUR can cross the placenta during pregnancy and the presence of the YTE modification may prolong and increase exposure to the infant exposed in utero. The impact of transmission to the fetus should be considered. Pregnant women exposed to EXDENSUR, or their healthcare providers, should report EXDENSUR exposure by calling 1-888-825-5249.

Please see full Prescribing Information for EXDENSUR.

To report SUSPECTED ADVERSE REACTIONS, contact GSK at gsk.public.reportum.com or 1-888-825-5249 or
FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

References

  1. Singh D, Fuhr R, Bird NP, et al. A phase 1 study of the long-acting anti-IL-5 monoclonal antibody GSK3511294 in patients with asthma. Br J Clin Pharmacol. 2022;88(2):702-712. 

  2. Liddament M, Husten J, Estephan T, et al. Allergy Asthma Immunol Res. 2019 Mar;11(2):291-298

  3. Data on file, GSK.