GSK has taken another strategic step in its biologics pipeline by submitting a New Drug Submission (NDS) to Health Canada for depemokimab, a monoclonal antibody aimed at two challenging inflammatory conditions: type 2 inflammation-associated asthma and chronic rhinosinusitis with nasal polyps (CRSwNP).
The submission is backed by positive Phase III trial data from the SWIFT and ANCHOR studies, which demonstrated the potential of depemokimab to provide sustained clinical benefits with just two injections per year.
A Potential First-in-Class Ultra-Long-Acting Biologic
Depemokimab targets interleukin-5 (IL-5), a key cytokine involved in the development and maintenance of type 2 inflammation. If approved, the drug could offer a novel treatment option for:
Adolescents (12+) and adults with eosinophilic asthma who require an add-on maintenance therapy.
Adults with inadequately controlled CRSwNP, a chronic inflammatory condition that significantly affects quality of life through symptoms like nasal obstruction, facial pressure, loss of smell, and recurrent infections.
While the drug is still under investigation and has not yet been approved in any country, GSK's application signals confidence in its efficacy and safety profile.
What This Means for the UK Biotech Sector
Although this submission is to Canadian regulators, it reflects GSK’s broader ambition to bring innovative, long-acting biologics to global markets, including the UK. For British patients, particularly those ineligible for or unresponsive to existing biologic treatments, depemokimab could eventually offer a less frequent and potentially more convenient dosing schedule - just one injection every six months.
Such advances are particularly relevant for the NHS, which continues to seek cost-effective therapies that reduce patient burden and treatment administration time.
Michelle Horn, GSK Canada’s country medical director, commented:
“Backed by strong clinical evidence, depemokimab has the potential to become the first ultra-long-acting biologic offering patients sustained inhibition of IL-5, a key driver of their disease... [It] represents a promising advancement for patients and physicians alike.”
Building on a Momentum of Canadian Approvals
This isn’t GSK’s first success in Canada. In November 2024, the company received Health Canada approval for Ojjaara (momelotinib), for the treatment of myelofibrosis in adults with moderate-to-severe anaemia.
The depemokimab submission continues GSK’s effort to diversify its respiratory and immunology portfolio, and UK-based biotech observers will be watching closely for subsequent filings in the UK and EU.
