GSK plc secured FDA approval for *Exdensur* (depemokimab-ulaa), a novel biologic targeting severe asthma with an eosinophilic phenotype in adults and adolescents aged 12 and older. This approval marks a significant advancement, offering an ultra-long-acting treatment with a twice-yearly dosing regimen, a first in its class.
The regulatory green light is underpinned by compelling data from the SWIFT-1 and SWIFT-2 Phase III clinical trials. These trials demonstrated that *Exdensur*, when administered as an add-on to standard care, significantly reduced the annualized rate of asthma exacerbations. Specifically, patients receiving depemokimab experienced a 58% reduction in SWIFT-1 and a 48% reduction in SWIFT-2 compared to placebo over a 52-week period. The drug also showed a notable decrease in exacerbations requiring hospitalization or emergency department visits, with a 72% reduction in the annualized rate of clinically significant exacerbations in a pooled analysis.
This breakthrough addresses a critical unmet need in severe asthma management. An estimated 2 million Americans suffer from severe asthma, with a substantial portion continuing to experience frequent, debilitating exacerbations. The introduction of *Exdensur* offers a potential paradigm shift, moving towards sustained disease control with a less frequent dosing schedule. This could translate into improved patient adherence, reduced healthcare burden, and enhanced quality of life for those living with this chronic condition.
Kaivan Khavandi, SVP & Global Head of Respiratory, Immunology & Inflammation R&D at GSK, highlighted the transformative potential of *Exdensur*, stating, “Physicians in the US now have the option to provide sustained protection from exacerbations for patients living with severe asthma with an eosinophilic phenotype in just two doses a year. *Exdensur* could redefine patient care and further establish the use of biologics for those who continue to experience exacerbations despite treatment.”
The extended half-life of depemokimab is a key technological differentiator, enabling sustained suppression of the underlying type 2 inflammation that drives the disease. This pharmacological characteristic is crucial for achieving the twice-yearly dosing, which is anticipated to be a significant convenience factor for patients and a driver for increased biologic uptake. Current data suggests that only about 20% of eligible patients in the US receive biologic therapy for severe asthma, indicating substantial room for growth and improvement in treatment access.
Geoffrey Chupp, MD, Professor of Medicine at Yale University, commented on the clinical implications, noting, “Current biologic treatments for asthma are often underutilized and frequent injections can be inconvenient for many patients and lead to inconsistent use. There is clearly an opportunity to provide a longer duration of protection from exacerbations between injections for severe asthma patients that reduces the frequency of doses and may improve overall health care utilization. *Exdensur* could empower physicians and patients to potentially achieve their treatment goals with fewer injections.”
Patient advocacy groups have also welcomed the news. Tonya Winders, President and CEO of the Global Allergy & Airways Patient Platform, expressed optimism, stating, “The struggle for people living with severe asthma is immense, with many silently enduring continued symptom recurrence and exacerbations. An innovative treatment option like *Exdensur* that offers the long-acting protection from exacerbations that severe asthma patients with an eosinophilic phenotype deserve, with the benefit of fewer doses, is truly welcome.”
Beyond the US, *Exdensur* has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), with an approval decision anticipated in Q1 2026. Regulatory submissions are also underway in other key markets, including China and Japan, underscoring GSK’s global strategy for this important new therapy.
The development program for depemokimab is extensive, encompassing trials not only in severe asthma but also in other type 2 inflammatory diseases such as chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic granulomatosis with polyangiitis (EGPA), and hypereosinophilic syndrome (HES). Furthermore, GSK is exploring its potential in chronic obstructive pulmonary disease (COPD) with type 2 inflammation, highlighting a broad application for this novel biologic platform.
**About Severe Asthma and *Exdensur***
Severe asthma is characterized by uncontrolled symptoms despite high-dose controller therapies, often driven by type 2 inflammation indicated by elevated eosinophil levels. *Exdensur* is a first-in-class ultra-long-acting biologic engineered for sustained efficacy in such conditions.
**Important Safety Information**
*Exdensur* carries potential risks including hypersensitivity reactions. It is not intended for the relief of acute bronchospasm or status asthmaticus. Patients should not abruptly discontinue corticosteroid therapy. The drug may also impact parasitic infections, and pregnant women exposed to *Exdensur* are advised to report exposure. Common adverse reactions include upper respiratory tract infections and allergic rhinitis.
The SWIFT trials’ results were published in the prestigious *New England Journal of Medicine*, reinforcing the robust clinical evidence supporting the approval of *Exdensur*. This approval positions GSK to further solidify its leadership in the respiratory therapeutic area.
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