GSK Receives Japanese Approval for Exdensur as Twice-Yearly Treatment for Severe Asthma and CRSwNP

GSK Receives Japanese Approval for Exdensur as Twice-Yearly Treatment for Severe Asthma and CRSwNP

(IN BRIEF) GSK has secured approval in Japan for Exdensur (depemokimab), the country’s first ultra-long-acting biologic for severe asthma and chronic rhinosinusitis with nasal polyps. Approved by Japan’s Ministry of Health, Labour and Welfare, the therapy delivers sustained disease control with twice-yearly dosing and is supported by robust phase III data from the SWIFT and ANCHOR trials. The decision follows earlier approvals in the US and UK and highlights Exdensur’s potential to reduce exacerbations, ease symptom burden, and simplify long-term management for patients with difficult-to-treat airway diseases.

(PRESS RELEASE) LONDON, 6-Jan-2026 — /EuropaWire/ — GSK plc has received regulatory approval in Japan for Exdensur (depemokimab), marking an important milestone for patients living with severe respiratory and inflammatory airway diseases. Japan’s Ministry of Health, Labour and Welfare has approved the ultra-long-acting biologic for the treatment of severe or refractory bronchial asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) in patients who remain inadequately controlled on existing standard therapies.

Exdensur becomes the first and only ultra-long-acting biologic available in Japan for these indications, offering sustained disease control with just two doses per year. The approval is based on results from the pivotal SWIFT and ANCHOR phase III programmes, which demonstrated consistent and durable efficacy when depemokimab was added to standard of care compared with placebo.

In patients with severe asthma, treatment with depemokimab significantly reduced the frequency of exacerbations over a 52-week period. Data from the SWIFT-1 and SWIFT-2 trials showed reductions in annualised asthma attacks of up to nearly 60%, highlighting the potential of twice-yearly dosing to provide long-term disease suppression. In CRSwNP, the ANCHOR-1 and ANCHOR-2 studies demonstrated meaningful improvements in nasal polyp size and nasal obstruction, two of the most burdensome symptoms for patients.

According to Kaivan Khavandi, Senior Vice President and Global Head of Respiratory, Immunology & Inflammation R&D at GSK, the approval represents a shift in treatment expectations for patients with severe disease. By maintaining suppression of type 2 inflammation throughout the year, Exdensur offers clinicians a new therapeutic option that may help reduce disease flare-ups and improve long-term outcomes with a simplified dosing schedule.

In Japan, people living with severe asthma often experience recurrent exacerbations, hospital admissions, and progressive loss of lung function, while patients with CRSwNP face chronic nasal blockage, loss of smell, sleep disturbance, and a high risk of recurrence despite surgery or systemic steroids. Depemokimab was engineered with an extended half-life to address these challenges, enabling sustained targeting of interleukin-5, a key driver of type 2 inflammation.

Across the SWIFT and ANCHOR clinical programmes, depemokimab demonstrated a safety profile comparable to placebo, with no meaningful differences in the rate or severity of adverse events. These findings support its use as a long-term maintenance therapy for appropriate patients.

The Japanese approval represents the third regulatory clearance for depemokimab globally, following authorisations from the US Food and Drug Administration and the Medicines and Healthcare products Regulatory Agency. The therapy has also received a positive opinion from the Committee for Medicinal Products for Human Use and is currently under regulatory review in additional markets, including China.

GSK continues to evaluate depemokimab across a broader development programme targeting other diseases driven by type 2 inflammation, reinforcing the company’s ambition to redefine long-term disease control in respiratory and immunology care.

About asthma

Asthma affects more than 260 million people globally, many of whom continue to experience symptoms and exacerbations despite treatment.11,12 Severe asthma is defined as asthma that requires treatment with medium- to high-dose inhaled corticosteroids plus a second therapy (i.e., systemic corticosteroid or biologic) to prevent it from becoming uncontrolled, or which remains uncontrolled despite therapy.13 Type 2 inflammation is the underlying cause of pathology in more than 80% of patients with severe asthma, in which patients exhibit elevated levels of eosinophils (a type of white blood cell).13

About CRSwNP

CRSwNP is caused by inflammation of the nasal lining that can lead to soft tissue growths, known as nasal polyps.14,15 People with CRSwNP experience symptoms such as nasal obstruction, loss of smell, facial pain, sleep disturbance, infections and nasal discharge that can significantly affect their emotional and physical well-being.14,15  Similar to asthma, the majority of cases of CRSwNP (85%) are driven by chronic type 2 inflammation, which is strongly associated with comorbidities, more severe disease, recurring symptoms and tissue remodelling.14-19

About Exdensur (depemokimab)

Exdensur is the first ultra-long-acting biologic being evaluated for certain respiratory diseases with underlying type 2 inflammation, such as severe asthma. It combines high interleukin-5 (IL-5) binding affinity and high potency with an extended half-life to enable twice-yearly dosing.1,2 IL-5 is a key cytokine in type 2 inflammation.

Please refer to the updated Product Information (PI) for precautions concerning indications, dosage and administration, and safety information in Japan which will shortly be updated at this link: Japan Pharmaceuticals and Medical Devices Agency.

About the SWIFT phase III trials

Results from the SWIFT trials were presented at the 2024 European Respiratory Society International Conference and published in the New England Journal of Medicine.1,20

The SWIFT-1 and SWIFT-2 clinical trials assessed the efficacy and safety of depemokimab adjunctive therapy in 382 and 380 participants with severe asthma who were randomised to receive depemokimab or a placebo respectively, in addition to their standard of care (SOC) treatment with medium to high-dose inhaled corticosteroids plus at least one additional controller. The full analysis set in SWIFT-1 included 250 patients in the depemokimab plus SOC arm and 132 in the placebo plus SOC arm; in SWIFT-2, 252 patients were included in the depemokimab plus SOC arm and 128 in the placebo plus SOC arm.1

About the ANCHOR phase III trials

Results from the ANCHOR trials were presented at the 2025 American Academy of Allergy, Asthma and Immunology (AAAAI) and World Allergy Organization (WAO) Joint Congress and published in The Lancet.2,21

ANCHOR-1 included 143 patients in the depemokimab plus SOC arm and 128 in the placebo plus SOC arm; in ANCHOR-2, 129 patients were included in the depemokimab plus SOC arm and 128 in the placebo plus SOC arm. All 528 patients had inadequately controlled CRSwNP, including nasal polyps in both nasal cavities (an endoscopic bilateral NPS ≥5), and had either undergone previous surgery for CRSwNP, had received previous treatment with SCS or were intolerant to SCS. Patients received depemokimab or placebo at six-monthly intervals (26 weeks) in addition to SOC (maintenance intranasal corticosteroids).2

About the depemokimab development programme

Depemokimab is currently being evaluated in phase III trials for the treatment of other diseases with underlying type 2 inflammation, including OCEAN for eosinophilic granulomatosis with polyangiitis (EGPA) and DESTINY for hyper eosinophilic syndrome (HES).22,23 GSK has also initiated the ENDURA-1, ENDURA-2 and VIGILANT phase III trials assessing the efficacy and safety of depemokimab as an add-on therapy in patients with uncontrolled moderate to severe COPD with type 2 inflammation.24-26

About GSK in respiratory

GSK continues to build on decades of pioneering work to deliver more ambitious treatment goals, develop the next generation standard of care and redefine the future of respiratory medicine for hundreds of millions of people with respiratory diseases. With an industry-leading respiratory portfolio and pipeline of vaccines, targeted biologics and inhaled medicines, GSK is focused on improving outcomes and the lives of people living with all types of asthma and COPD, along with less understood refractory chronic cough or rarer conditions like systemic sclerosis with interstitial lung disease. GSK is harnessing the latest science and technology with the aim of modifying the underlying disease dysfunction and preventing progression.

About GSK

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. Find out more at gsk.com.

Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the “Risk Factors” section in GSK’s Annual Report on Form 20-F for 2024, and GSK’s Q3 Results for 2025.

References

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2. Gevaert, P, et al. “Efficacy and safety of twice per year depemokimab in chronic rhinosinusitis with nasal polyps (ANCHOR-1 and ANCHOR-2): Phase 3, randomised, double-blind, Parallel Trials.” The Lancet, vol. 405, no. 10482, Mar. 2025, pp. 911–926, https://doi.org/10.1016/s0140-6736(25)00197-7.
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