On 20 May 2025 at the American Thoracic Society (ATS) International Conference in San Francisco, a poster presentation by GlaxoSmithKline (GSK) provided insight into the therapeutic benefit of depemokimab for improving disease symptoms in patients with asthma.  Depemokimab, GSK’s long-acting, anti-interleukin (IL)-5 monoclonal antibody (mAB), is currently under review as an add-on maintenance treatment for asthma in paediatric (≥12 years old) and adult patients, as well as adult patients with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). With an answer to the biologics licence application (BLA) expected from the US Food and Drug Administration near the end of the year and the Prescription Drug User Fee Act set for 16 December, the company further strengthens its argument for regulatory approval of depemokimab through presenting the clinical outcomes of the agent in asthmatic patients with uncontrolled disease symptoms.Â
For asthma, the BLA application was based on clinical results from the Phase 3 SWIFT-1/-2 studies. Depemokimab was shown to significantly reduce exacerbations with sustained inhibition of type 2 inflammation observed in patients with type 2 asthma characterised by blood eosinophils. However, uncontrolled asthma symptoms were not required for study inclusion, so patients with any baseline Asthma Control Questionnaire-5 (ACQ-5) score were eligible. At ATS, investigators presented post hoc subgroup analysis of pooled SWIFT-1/2 data outcomes of uncontrolled asthma symptoms (ACQ-5 score ≥1.5) in response to depemokimab.Â
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The convenience of twice-yearly dosage is a clear point of distinction
Depemokimab was shown to reduce the annualised exacerbation rate for patients with controlled and uncontrolled asthma symptoms, 53% and 54% respectively. Depemokimab-treated patients with uncontrolled asthma symptoms (ACQ ≥1.5) at baseline were shown to have clinically meaningful improvement at Week 52, with 69% classed as responders based on their St George’s Respiratory Questionnaire (SGRQ) score versus 63% of placebo-treated patients.  In patients characterised as controlled-disease (ACQ-4 score < 1.5), 51% of depemokimab-treated patients and 55% of placebo-treated patients were classified as responders.Â
With many currently approved biologics in the severe asthma market and additional drugs to enter the space in the coming years, GSK faces stiff competition. However, unlike other therapies, depemokimab’s dosing schedule requires administration only twice per year. The convenience of such a long-acting agent will be a clear point of distinction that GSK will certainly re-inforce in product messaging. The favourable dosing schedule of depemokimab and its significant impact on disease management has been echoed in recent interviews by GlobalData of key opinion leaders (KOLs), to GSK’s benefit.
US KOLS have stated: “Depemokimab, with its extended dosing interval, could address adherence issues for patients who struggle with frequent injections,” and that “the emergence of biologics has been revolutionary for severe asthma, and the introduction of longer-acting therapies administered just twice a year will further improve adherence and patient outcomes.”
GSK can also now report that depemokimab has been shown to reduce exacerbations regardless of baseline asthma control, suggesting that uncontrolled asthma symptoms are not necessary to experience a response. Ultimately, with the clinical findings and the ease of biannual dosing, depemokimab is expected to have robust and quick adoption by healthcare providers and physicians upon regulatory approval. Â Anticipating regulatory approval late in 2025 and a product launch in the US in the first quarter of 2026, GlobalData forecasts total sales to reach $513 million in the first year on the market and surpass $1 billion by 2028.
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By GlobalData
