FDA Approves Extremely-long-acting Biologic Depemokimab for Bronchial asthma

Depemokimab is a twice-yearly administered monoclonal antibody authorised for sufferers with extreme bronchial asthma with an eosinophilic phenotype.

RT’s Three Key Takeaways:

1. FDA Approval Milestone – Exdensur (depemokimab-ulaa) was authorised as an add-on upkeep therapy for extreme eosinophilic bronchial asthma in sufferers aged 12 and older, changing into the primary ultra-long-acting biologic on this area with twice-yearly dosing.
2. Sturdy Scientific Efficacy – Part III SWIFT-1 and SWIFT-2 trials confirmed Exdensur diminished annual bronchial asthma exacerbations by as much as 58% versus placebo and lower hospitalizations or emergency visits by 72%, whereas sustaining a security profile corresponding to placebo.
3. Improved Entry and Adherence Potential – By lowering injections to 2 doses per 12 months, Exdensur could assist deal with underuse of biologics in extreme bronchial asthma, providing a extra handy choice that would enhance affected person adherence and long-term illness management.

The US FDA authorised Exdensur (depemokimab-ulaa) as an add-on upkeep therapy of extreme bronchial asthma characterised by an eosinophilic phenotype in grownup and pediatric sufferers aged 12 years and older, in accordance with GlaxoSmithKline.

Exdensur is the primary ultra-long-acting biologic being evaluated for sure respiratory ailments with underlying sort 2 irritation, similar to extreme bronchial asthma. It has been developed with an prolonged half-life to allow twice-yearly dosing.¹

The FDA approval of Exdensur relies on knowledge from the SWIFT-1 and SWIFT-2 part III trials. In these research, depemokimab demonstrated sustained exacerbation discount with two doses per 12 months versus placebo, each plus commonplace of care. Remedy with depemokimab resulted in a major 58% and 48% discount within the fee of annualized bronchial asthma exacerbations (bronchial asthma assaults) over 52 weeks from SWIFT-1 and SWIFT-2, respectively [rate ratio (95% confidence interval) p-value: SWIFT-1 0.42 (0.30, 0.59) p<0.001 and SWIFT-2 0.52 (0.36, 0.73) p<0.001] (AER depemokimab versus placebo: SWIFT-1 0.46 vs. 1.11 and SWIFT-2 0.56 vs. 1.08 exacerbations per 12 months).¹

In a secondary endpoint from SWIFT-1 and SWIFT-2, sufferers handled with depemokimab skilled numerically fewer exacerbations requiring hospitalization and/or emergency division visits (1% and 4%) in contrast with placebo (8% and 10%), respectively. A pre-specified pooled evaluation of the 2 trials confirmed there was a 72% discount within the annualized fee of clinically important exacerbations requiring hospitalization and/or ED visits over 52 weeks for depemokimab in contrast with placebo [rate ratio 0.28, 95% CI (0.13, 0.61), nominal p=0.002] (AER depemokimab 0.02 versus placebo 0.09). Throughout these trials, depemokimab was well-tolerated, with sufferers experiencing the same fee and severity of unwanted effects as these receiving placebo.¹

“Physicians within the US now have the choice to supply sustained safety from exacerbations for sufferers dwelling with extreme bronchial asthma with an eosinophilic phenotype in simply two doses a 12 months. Exdensur may redefine affected person care and additional set up the usage of biologics for many who proceed to expertise exacerbations regardless of therapy,” stated Kaivan Khavandi, SVP & World Head, Respiratory, Immunology & Irritation R&D.

An estimated 2 million Individuals reside with extreme bronchial asthma and half proceed to expertise frequent exacerbations that will result in hospitalizations, emergency division visits and corresponding elevated well being system prices.^2,3,4 Whereas biologics have demonstrated profit in controlling extreme bronchial asthma, solely 20% of eligible sufferers within the US presently obtain one, rising their danger of exacerbations and worsening illness.⁵ Longer dosing intervals have been related to an elevated probability that sufferers would think about a biologic and 73% of physicians imagine it might be useful.^6,7

Geoffrey Chupp, MD, Professor of Drugs, Pulmonary, Vital Care and Sleep Drugs, Yale College stated: “Present biologic remedies for bronchial asthma are sometimes underutilized and frequent injections could be inconvenient for a lot of sufferers and result in inconsistent use. There’s clearly a chance to supply an extended period of safety from exacerbations between injections for extreme bronchial asthma sufferers that reduces the frequency of doses and will enhance total well being care utilization. Exdensur may empower physicians and sufferers to probably obtain their therapy objectives with fewer injections.”

Tonya Winders, President and CEO, World Allergy & Airways Affected person Platform stated: “The wrestle for folks dwelling with extreme bronchial asthma is immense, with many silently enduring continued symptom recurrence and exacerbations. An progressive therapy choice like Exdensur that gives the long-acting safety from exacerbations that extreme bronchial asthma sufferers with an eosinophilic phenotype deserve, with the advantage of fewer doses, is actually welcome.”

Depemokimab lately obtained a constructive CHMP opinion in Europe, with an approval choice anticipated in Q1 2026. Regulatory submissions are additionally beneath assessment throughout the globe, together with in China and Japan. 

For security knowledge and prescribing data, please go to GSK. [PDF]

References

1. Jackson, David J., et al. “Twice-yearly Depemokimab in extreme bronchial asthma with an eosinophilic phenotype.” New England Journal of Drugs, vol. 391, no. 24, 19 Dec. 2024, pp. 2337–2349, 
2. Wang, Eileen, et al. “Characterization of extreme bronchial asthma worldwide.” CHEST, vol. 157, no. 4, Apr. 2020, pp. 790–804, 
3. Menzies-Gow, Andrew, et al. “A renewed constitution: Key rules to enhance affected person care in extreme bronchial asthma.” Advances in Remedy, vol. 39, no. 12, 17 Oct. 2022, pp. 5307–5326, 
4. “Price of Bronchial asthma on Society.” Price of Bronchial asthma on Society, Bronchial asthma & Allergy Basis of America, 31 Jan. 2025, 
5. Park, Jihye, et al. “Unmet therapy wants in bronchial asthma sufferers with eosinophilic phenotype: A US claims-based examine on bronchial asthma exacerbations and Healthcare Useful resource Utilization.” CHEST, vol. 166, no. 4, Oct. 2024, 
6. Tal-Singer, Ruth, et al. “Illness influence and notion of biologics in adults with sort 2 irritation respiratory illness: Worldwide survey outcomes.” Affected person Choice and Adherence, Quantity 19, Apr. 2025, pp. 1159–1170, 
7. Analysis Partnership Quant uptake Market Analysis, 200 HCPs Prime two field on a seven-point scale the place seven equaled “extremely useful”.
8. Brussino, Luisa, et al. “Is it extreme bronchial asthma or bronchial asthma with extreme comorbidities?” Journal of Bronchial asthma and Allergy, Quantity 10, Nov. 2017, pp. 303–305, 
9. Heaney, Liam G., et al. “Eosinophilic and noneosinophilic bronchial asthma.” CHEST, vol. 160, no. 3, Sept. 2021, pp. 814–830, 
10. “An Open-Label Extension Examine of GSK3511294 (Depemokimab) in Individuals Who Had been Beforehand Enrolled in 206713 (NCT04719832) or 213744 (NCT04718103) (AGILE).” ClinicalTrials.gov, GlaxoSmithKline, clinicaltrials.gov/examine/NCT05243680. Accessed 8 Dec. 2025.
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