GSK has made a new drug submission (NDS) to Health Canada for the monoclonal antibody, depemokimab, targeting two specific conditions.
The first proposed indication is for the use as an add-on maintenance treatment for asthma in individuals aged 12 years and above with type 2 inflammation marked by an eosinophilic phenotype.
Go deeper with GlobalData
The second is for treating adults with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).
Depemokimab targets interleukin-5 (IL-5), which plays a crucial role in type 2 inflammation.
GSK’s submission is supported by the positive Phase III SWIFT and ANCHOR trial data.
These trials have demonstrated that the antibody could provide sustained inhibition of a key disease driver and assist in achieving clinical outcomes with two injections annually.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataThe extended half-life and binding affinity of the antibody support a dosing regimen of a single injection every six months.
Patients with CRSwNP often suffer from symptoms such as loss of smell, facial pain, nasal obstruction, sleep disturbance, nasal discharge and infections.
The effectiveness and safety of the antibody are still being investigated, and it has neither been granted any authorisation nor approved for use in any nation at present.
GSK Canada country medical director Michelle Horn stated: “The combined submission for asthma and CRSwNP marks a significant step toward addressing the unmet needs of patients.
“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 with twice-yearly dosing, and represents a promising advancement for patients and physicians alike.”
In November 2024, GSK secured Health Canada’s approval for Ojjaara (momelotinib) to treat myelofibrosis in adults with moderate-to-severe anaemia.
