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LONDON — The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for the world’s first twice-yearly biologic therapy for severe asthma and chronic rhinosinusitis, marking a significant shift in the management of respiratory diseases.
The drug, depemokimab—to be marketed under the brand name Exdensur—was authorized on December 15, 2025, for use in adults and adolescents aged 12 and older with severe asthma involving type 2 inflammation. It was simultaneously approved for adults with severe chronic rhinosinusitis with nasal polyps (CRSwNP).
This regulatory milestone offers a new therapeutic option for patients whose conditions remain uncontrolled despite standard daily treatments, potentially reducing the burden of frequent injections associated with current biologic therapies.
Breaking the Cycle of Frequent Treatment
Severe asthma affects approximately 200,000 people in the UK. For many, the condition is driven by “type 2 inflammation,” an immune response characterized by elevated levels of eosinophils, a type of white blood cell that causes airway swelling and mucus production.
Until now, biologic treatments targeting this pathway—such as mepolizumab (Nucala) or benralizumab (Fasenra)—typically required injections every four to eight weeks. Exdensur represents a new class of “ultra-long-acting” biologics that can be administered just once every six months.
“This approval represents another potential treatment option for patients living with some forms of these conditions whose symptoms have not been adequately controlled with current therapies,” said Julian Beach, Interim Executive Director of Healthcare Quality and Access at the MHRA.
Clinical Evidence: Halving Asthma Attacks
The MHRA’s decision was based on data from an extensive Phase III clinical development program, including the SWIFT-1 and SWIFT-2 trials for asthma and the ANCHOR-1 and ANCHOR-2 trials for nasal polyps.
In the pooled analysis of the SWIFT asthma trials, depemokimab demonstrated a 54% reduction in the annualized rate of clinically significant exacerbations (asthma attacks) compared to a placebo over 52 weeks. perhaps most notably, the data showed a 72% reduction in severe exacerbations requiring hospitalization or emergency department visits.
“Many patients with severe asthma continue to face frequent exacerbations, hospital visits, and exposure to chronic oral corticosteroids,” said Kaivan Khavandi, Senior Vice President and Global Head of Respiratory, Immunology & Inflammation R&D at GSK. “In just two doses a year, depemokimab could help redefine care for millions of patients.”
For patients with chronic rhinosinusitis with nasal polyps (CRSwNP), the ANCHOR trials showed that the drug significantly reduced nasal polyp size and nasal obstruction symptoms compared to the standard of care alone.
Mechanism of Action
Depemokimab acts as an interleukin-5 (IL-5) inhibitor. IL-5 is a key protein (cytokine) responsible for the growth, activation, and survival of eosinophils. By binding to IL-5 with high potency and a long half-life, depemokimab prevents these cells from causing inflammation, effectively “switching off” the driver of the disease for an extended period.
Implications for Patient Care and Adherence
The shift from monthly to biannual dosing is expected to address a critical challenge in chronic disease management: treatment adherence.
“The convenience of a twice-yearly dosage is a clear point of distinction,” noted stakeholders from Asthma + Lung UK during the consultation process for the drug’s appraisal. Patient advocacy groups have long highlighted that reducing the frequency of injections can significantly improve quality of life and ensure consistent protection against attacks, particularly for younger patients or those with busy lifestyles.
Dr. Sarah Jenkins, a respiratory consultant not involved in the trials, commented on the practical impact: “For a teenager who has to miss school or a working adult who has to schedule monthly clinic visits, moving to two appointments a year is transformative. It changes the psychological weight of the disease from a constant monthly reminder to a background maintenance issue.”
Limitations and Safety Profile
While the efficacy data is robust, the treatment is not suitable for all asthma patients. It is specifically indicated for those with an “eosinophilic phenotype”—meaning it will not work for patients whose asthma is driven by other inflammatory pathways (non-type 2 asthma).
Safety data from the trials indicated that depemokimab was generally well-tolerated. The most common side effects reported included:
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Injection site reactions (pain or redness)
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Headache
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Fatigue
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Itchy skin
The MHRA has stated it will keep the safety and effectiveness of the drug under close review, as is standard for all new biological medicines.
The Road to NHS Access
Regulatory approval allows the drug to be marketed in the UK, but it does not guarantee immediate availability on the National Health Service (NHS). The National Institute for Health and Care Excellence (NICE) is currently conducting a technology appraisal to determine if Exdensur represents good value for money for the taxpayer.
A final guidance from NICE is expected later in 2026. Until then, the drug may only be available via private prescription or specific early-access schemes.
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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Regulatory Announcement: Medicines and Healthcare products Regulatory Agency (MHRA). (2025). UK approves the first twice yearly biological medicine for asthma and severe chronic rhinosinusitis with nasal polyps. GOV.UK.
