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07 Jan 2026
Admin
News Article

GSK Secures Japan Approval for Exdensur in Severe Asthma and CRSwNP

GSK has achieved another major regulatory milestone in respiratory medicine.

Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Exdensur (depemokimab) for the treatment of severe or refractory bronchial asthma and chronic rhinosinusitis with nasal polyps (CRSwNP).

The approval applies to patients whose disease remains uncontrolled despite standard therapies.

What Makes This Approval Significant?

Exdensur introduces a new treatment paradigm. It is designed for twice-yearly dosing, offering sustained suppression of disease-driving type 2 inflammation with just two injections per year.

For patients with severe disease, this could mean fewer exacerbations, improved symptom control, and reduced treatment burden.

Clinical Evidence Supporting the Decision

The MHLW approval was based on results from four phase III trials:

SWIFT-1 and SWIFT-2 in severe asthma
ANCHOR-1 and ANCHOR-2 in CRSwNP

All studies evaluated depemokimab versus placebo, added to standard of care.

Key Results From the SWIFT Asthma Trials

Depemokimab delivered consistent and clinically meaningful outcomes.

Over 52 weeks, patients experienced:

58% reduction in annualised asthma exacerbations in SWIFT-1
48% reduction in SWIFT-2

These reductions were statistically significant and sustained throughout the study period.

Strong Outcomes in CRSwNP From ANCHOR Trials

Patients with uncontrolled CRSwNP also benefited. At 52 weeks, depemokimab showed:

Significant reductions in nasal polyp size
Meaningful improvements in nasal obstruction

Both outcomes reflect improvements in daily symptoms and disease severity.

Safety and Tolerability Profile

Across all trials, depemokimab was well tolerated. The rate and severity of side effects were similar to placebo, reinforcing its suitability for long-term use.

Why Twice-Yearly Dosing Matters?

Depemokimab was engineered with an extended half-life.

This enables:

Sustained IL-5 inhibition
Reduced treatment frequency
Potential improvements in adherence and real-world outcomes

IL-5 plays a central role in eosinophil-driven type 2 inflammation.

Japan Joins a Growing List of Approvals

The Japan approval marks the third regulatory clearance for depemokimab.

It follows approvals from:

US Food and Drug Administration (FDA)
UK Medicines and Healthcare products Regulatory Agency (MHRA)

The drug has also received a positive CHMP opinion in the EU, with reviews ongoing in China and other markets.

The Broader Disease Context

Asthma affects over 260 million people worldwide. More than 80ison per cent of patients with severe asthma have underlying type 2 inflammation, often driven by elevated eosinophils.

CRSwNP shares similar biology, with around 85% of cases linked to chronic type 2 inflammation.

What’s Next for Depemokimab?

GSK is expanding depemokimab’s development program. Ongoing phase III studies include:

OCEAN for eosinophilic granulomatosis with polyangiitis
DESTINY for hypereosinophilic syndrome
ENDURA and VIGILANT trials in COPD with type 2 inflammation

The Takeaway

With Exdensur, GSK is pushing respiratory care toward longer-lasting, biologically targeted treatments.

Twice-yearly dosing, strong efficacy, and global regulatory momentum could redefine standards for severe asthma and CRSwNP management.

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