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London — In a significant development for respiratory medicine, European regulators have recommended the approval of depemokimab (Exdensur), a novel biologic therapy designed to treat severe eosinophilic asthma and chronic rhinosinusitis with nasal polyps (CRSwNP). If formally approved by the European Commission, the drug would become the first ultra-long-acting biologic for these conditions, requiring just two doses a year to maintain symptom control.
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on December 13, 2025, backing the therapy as an add-on maintenance treatment. The recommendation is seen as a pivotal step toward reducing the treatment burden for millions of patients who currently rely on daily medications or frequent monthly injections.
A “Paradigm Shift” in Dosing
The clearance covers two distinct but often co-occurring conditions: severe asthma with type 2 inflammation and severe chronic rhinosinusitis with nasal polyps. Both conditions are driven by eosinophils, a type of white blood cell that causes inflammation in the airways.
Depemokimab, developed by GSK, is a monoclonal antibody that targets interleukin-5 (IL-5), a key cytokine responsible for the maturation and survival of eosinophils. While other IL-5 inhibitors exist—such as mepolizumab (Nucala) and benralizumab (Fasenra)—depemokimab is distinct due to its high potency and extended half-life.
“The prospect of a six-month dosing schedule represents a potential paradigm shift in how we manage severe respiratory diseases,” said Dr. Dean Edell, a pulmonologist not involved in the drug’s development but who has tracked its clinical progress. “For patients who struggle with adherence or the logistical burden of monthly clinic visits, moving to a twice-yearly injection could significantly improve quality of life and long-term disease control.”
Clinical Trial Success: SWIFT and ANCHOR
The EMA’s recommendation was based on data from an extensive Phase 3 clinical development program involving four major trials: SWIFT-1 and SWIFT-2 for asthma, and ANCHOR-1 and ANCHOR-2 for nasal polyps.
In Severe Asthma:
The SWIFT trials evaluated the drug in adults and adolescents with severe asthma uncontrolled by standard high-dose inhalers.
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Key Finding: Patients receiving depemokimab experienced a 54% reduction in the annualized rate of clinically significant asthma exacerbations compared to placebo.
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Hospitalizations: The pooled analysis showed a 72% reduction in exacerbations requiring hospitalization or emergency department visits.
In Nasal Polyps (CRSwNP):
The ANCHOR trials focused on patients with nasal polyps who continued to suffer symptoms despite corticosteroid treatment or previous surgery.
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Key Finding: Depemokimab demonstrated statistically significant improvements in endoscopic nasal polyp scores and nasal obstruction symptoms compared to placebo.
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Impact: The drug helped patients avoid the need for systemic steroids and repeat sinus surgeries, which are common interventions for severe cases.
“Many patients with severe asthma continue to face frequent exacerbations and exposure to chronic oral corticosteroids,” noted Kaivan Khavandi, Senior Vice President and Global Head of Respiratory R&D at GSK, in a statement following the decision. “In just two doses a year, depemokimab could help redefine care for millions of patients.”
Addressing the “Type 2” Inflammation Burden
Type 2 inflammation is a specific immune response that underlies approximately 50% to 70% of severe asthma cases and a large proportion of nasal polyp cases. Patients with this phenotype often have high levels of eosinophils in their blood and tissues.
Current biologic treatments for this pathway typically require administration every 4 to 8 weeks. By modifying the antibody’s structure to last longer in the body, depemokimab offers “extended coverage” that aligns more closely with routine biannual check-ups than with active monthly management.
Safety and Side Effects
The safety profile of depemokimab in the Phase 3 trials was generally consistent with other eosinophil-targeting biologics. The most common adverse events reported included:
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Injection site reactions (pain or redness)
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Nasopharyngitis (common cold symptoms)
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Headache
The committee noted that the benefits of sustained disease control and reduced exacerbations outweighed these risks.
Implications for Patients and Healthcare
This recommendation comes at a time of rapid innovation in respiratory care. In October 2025, the FDA approved another biologic, tezepelumab (Tezspire), for nasal polyps, giving patients more options than ever before. However, depemokimab’s dosing schedule sets it apart.
“We often see ‘injection fatigue’ in patients on long-term biologic therapy,” explains Dr. Sarah Jensen, an allergist and immunologist at the University of Zurich Hospital. “A treatment that works in the background for six months allows patients to feel less like ‘patients’ and more like people living their lives. It normalizes their routine.”
However, experts caution that access will be a key hurdle. Biologics are expensive therapies, typically reserved for the most severe cases where cheaper inhalers and pills have failed. “The efficacy is clear, but payers and health systems will need to evaluate the cost-effectiveness of this long-acting option versus established monthly therapies,” Dr. Jensen added.
What’s Next?
The CHMP’s positive opinion is a formal recommendation to the European Commission, which usually issues a final legally binding approval decision within 67 days. A decision from the U.S. Food and Drug Administration (FDA) is also expected imminently, with a target action date set for mid-December 2025.
If approved, depemokimab will be marketed under the brand name Exdensur in Europe.
Medical Disclaimer: This article is for informational purposes only and should not be considered medical advice. Always consult with qualified healthcare professionals before making any health-related decisions or changes to your treatment plan. The information presented here is based on current research and expert opinions, which may evolve as new evidence emerges.
References
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European Medicines Agency (EMA). (2025). Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 8-11 December 2025. Amsterdam, Netherlands.
