GSK has submitted a New Drug Submission (NDS) to Health Canada for depemokimab for two proposed indications: The first indication is as an add-on maintenance treatment of asthma in adult and adolescent patients aged 12 years and older with type 2 inflammation characterized by an eosinophilic phenotype on medium- to high-dose inhaled corticosteroids (ICS) plus another asthma controller. The second indication is as an add-on maintenance treatment of adult patients with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). The NDS is based on data from the positive SWIFT and ANCHOR trials.
Michelle Horn, Country Medical Director, GSK Canada, said: “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.”
Depemokimab, a monoclonal antibody that targets IL-5, is the first ultra-long-acting biologic to be evaluated in phase III trials. IL-5 is a key cytokine (protein) in type 2 inflammation. Type 2 inflammation is typically identified by blood eosinophil count and is an underlying driver in many diseases. This type of inflammation is present in the majority of patients with difficult to treat asthma and can lead to exacerbations and hospitalization. Type 2 inflammation is also present in up to 85% of people with CRSwNP and is associated with more severe disease and symptoms. With IL-5 inhibition, eosinophils are significantly reduced and there is evidence to show IL-5 has broader effects on other structural and immune cell types beyond eosinophils.
In patients with asthma with type 2 inflammation and patients with CRSwNP, the SWIFT and ANCHOR trials, respectively, met their primary endpoints, showing that depemokimab could offer sustained inhibition of an important driver of their disease, and help achieve key clinical outcomes with a dosing schedule of just two injections per year. Depemokimab’s extended half-life, high-binding affinity and potency, support a dosing regimen of one injection every six months (26 weeks).. As demonstrated in studies of other diseases, longer intervals between doses have been shown to overcome barriers to optimal care, such as patient adherence, and can reduce the burden of disease for patients.
In Canada, more than 4.7 million people are currently affected by asthma, a chronic and sometimes debilitating condition. Many Canadian asthmatics continue to experience symptoms such as difficulty breathing and chest tightness, despite treatment with high-dose inhaled corticosteroids plus a second controller (and/or systemic corticosteroids).
People with CRSwNP experience symptoms such as nasal obstruction, loss of smell, facial pain, sleep disturbance, infections and nasal discharge that can significantly affect their emotional and physical well-being. Such symptoms mean the impact of CRSwNP on overall quality of life has been reported to be comparable with other chronic diseases such as COPD, asthma, and diabetes.
The safety and effectiveness of depemokimab are still under investigation and authorization has not yet been granted. Depemokimab is currently not approved for use in any country.