GSK seeks Health Canada OK for depemokimab in asthma, sinusitis

Toronto, May 2025 – GSK has officially submitted a New Drug Submission (NDS) to Health Canada for its investigational biologic depemokimab, aimed at treating two major conditions tied to type 2 inflammation: severe eosinophilic asthma and chronic rhinosinusitis with nasal polyps (CRSwNP).

If approved, depemokimab would become the first ultra-long-acting biologic targeting IL-5, with a convenient twice-yearly dosing schedule, offering a new standard of care for patients struggling with chronic respiratory diseases.

GSK Targets Unmet Needs in Asthma and CRSwNP

The dual submission follows encouraging results from GSK’s pivotal SWIFT and ANCHOR Phase III clinical trials. The therapy is designed as an add-on maintenance treatment for:

• Asthma in patients 12 years and older with type 2 inflammation and an eosinophilic phenotype, uncontrolled on medium- to high-dose ICS plus another controller.
• CRSwNP in adult patients not adequately managed by intranasal corticosteroids.

“This combined submission marks a significant step toward addressing the unmet needs of patients. Backed by strong clinical evidence, depemokimab has the potential to offer sustained IL-5 inhibition with just two injections per year,”

– said Michelle Horn, Country Medical Director, GSK Canada.

How Depemokimab Works?

Depemokimab is a monoclonal antibody targeting interleukin-5 (IL-5), a cytokine that plays a key role in type 2 inflammation. This inflammation is an underlying driver in diseases such as asthma and nasal polyps, especially in patients with elevated eosinophil counts.

Type 2 inflammation is implicated in:

• Majority of difficult-to-treat asthma cases, affecting over 4.7 million Canadians.
• Up to 85% of CRSwNP cases, which cause nasal congestion, facial pain, loss of smell, and sleep issues.

By inhibiting IL-5, depemokimab reduces eosinophils and may have additional effects on other immune and structural cells, potentially resetting the immune system’s overactive response.

Phase III Clinical Data: SWIFT & ANCHOR Trials

SWIFT-1 and SWIFT-2 assessed depemokimab’s safety and efficacy in patients with severe asthma. In both 52-week, placebo-controlled trials, the biologic showed a statistically significant reduction in asthma exacerbations compared to placebo. Results were published in the New England Journal of Medicine.

ANCHOR-1 and ANCHOR-2 focused on adult CRSwNP patients. Conducted across multiple centers, these 52-week trials demonstrated significant reductions in nasal polyp size and nasal obstruction. Full data is available in The Lancet.

Both trials underline depemokimab’s extended half-life and high binding affinity, supporting its long-interval dosing.

Transforming Respiratory Care in Canada

Despite existing treatment options, many asthma patients in Canada remain symptomatic. Depemokimab’s twice-yearly injection schedule could improve patient adherence, reduce healthcare burdens, and minimize disease flare-ups.

For CRSwNP sufferers, who often experience reduced quality of life, depemokimab offers a new therapeutic avenue with a biologic proven to address core disease mechanisms.

What’s Next?

Depemokimab is not yet approved for use in Canada or elsewhere. Its safety and effectiveness remain under regulatory review. GSK’s submission reflects its ongoing commitment to developing innovative treatments for complex respiratory conditions.

About GSK’s Respiratory Pipeline

GSK is recognized as a global leader in respiratory medicine. With a robust portfolio spanning biologics, vaccines, and inhaled therapies, the company is actively investing in next-generation treatments for asthma, COPD, and lesser-known diseases like refractory chronic cough and systemic sclerosis with interstitial lung disease.

The pharmaceutical giant aims to modify disease progression, enhance patient outcomes, and set new standards in respiratory care.

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