• 17 Dec 2025
• Admin
• News Article

GSK Secures UK Approval for Exdensur, a Twice-Yearly Biologic for Severe Asthma and Nasal Polyps

GSK has received UK marketing authorisation for Exdensur (depemokimab) from the Medicines and Healthcare products Regulatory Agency (MHRA), marking the first global approval for this ultra-long-acting biologic.

The approval positions Exdensur as a new treatment option for patients with type 2 inflammatory respiratory diseases, offering sustained control with just two doses per year.

What Is Exdensur Approved For?

In the UK, Exdensur is approved in two indications:

1. Severe Type 2 Asthma

As an add-on maintenance therapy for:

• Adults and adolescents aged 12 years and older
• Patients with eosinophilic asthma
• Those inadequately controlled on moderate- to high-dose inhaled corticosteroids (ICS) plus another controller

2. Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

As an add-on therapy with intranasal corticosteroids for:

• Adult patients with severe CRSwNP
• Individuals who remain uncontrolled despite systemic corticosteroids and/or surgery

Why This Approval Matters?

Asthma affects more than 260 million people globally and around 7 million in the UK. A significant proportion of patients with severe asthma continue to experience exacerbations despite existing therapies.

These flare-ups:

• Drive emergency department visits and hospitalisations
• Contribute to long-term lung damage
• Add growing pressure on healthcare systems, with NHS asthma costs projected to rise 22% by 2031

CRSwNP presents a similar burden, with debilitating symptoms such as nasal obstruction, loss of smell, facial pain, and sleep disturbance—most driven by the same underlying type 2 inflammation.

Exdensur targets this root cause with a long-acting IL-5 pathway approach, potentially reducing both patient burden and healthcare utilisation.

Clinical Evidence Behind the Approval

The MHRA decision is supported by results from four phase III trials:

• SWIFT-1 and SWIFT-2 (asthma)
• ANCHOR-1 and ANCHOR-2 (CRSwNP)

Key Findings in Asthma (SWIFT Trials)

• 54% reduction in clinically significant asthma exacerbations over 52 weeks
• 72% reduction in exacerbations requiring hospitalisation or emergency care
• Sustained efficacy maintained for up to two years in the AGILE extension study
• Comparable safety profile to placebo

Key Findings in CRSwNP (ANCHOR Trials)

• Significant improvement in nasal polyp score
• Meaningful reduction in nasal obstruction symptoms
• Benefits sustained with six-monthly dosing

Across all studies, depemokimab was well tolerated, with side-effect rates similar to placebo.

What Makes Exdensur Different?

Exdensur is the first ultra-long-acting biologic being evaluated for respiratory diseases driven by type 2 inflammation.

Its key features include:

• High IL-5 binding affinity and potency
• Extended half-life, enabling twice-yearly dosing
• Reduced treatment burden compared to monthly or bi-monthly biologics

This dosing profile could significantly improve adherence and long-term disease control.

What GSK Is Saying?

According to Kaivan Khavandi, SVP and global head of respiratory, immunology and inflammation R&D at GSK:

“This ultra-long-acting biologic delivers sustained efficacy to reduce asthma exacerbations, keep patients out of hospital and help prevent cumulative lung damage in just two doses a year. This is a step change in respiratory treatment.”

What’s Next for Exdensur?

• Exdensur has already received a positive CHMP opinion in the EU
• Regulatory reviews are ongoing in the US, Japan, and China
• Approval decisions are expected from December 2025 through H1 2026

GSK is also evaluating depemokimab in additional type 2 inflammatory diseases, including:

• Eosinophilic granulomatosis with polyangiitis (EGPA)
• Hypereosinophilic syndrome (HES)
• Type 2 inflammation-driven COPD

The Bigger Picture

With Exdensur, GSK is pushing respiratory care toward:

• Longer-lasting biologics
• Lower treatment burden
• Earlier and more sustained disease control

If global approvals follow, depemokimab could redefine how severe asthma and CRSwNP are managed—moving from frequent injections to just two doses a year, without compromising efficacy.

This marks a notable shift in the evolution of biologics for chronic respiratory disease.