Depemokimab Accepted by EMA for Asthma Treatment
GSK plc announced that the EMA has accepted for review the Marketing Authorisation Application for the use of depemokimab in two indications
The submitted indications are for add-on maintenance treatment of asthma in adult and adolescent patients aged 12 years and older with type 2 inflammation characterised by an eosinophilic phenotype who are inadequately controlled on medium to high dose corticosteroids (ICS) plus another asthma controller and also as an add-on treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).
Kaivan Khavandi, SVP, Global Head of Respiratory/Immunology R&D, said “Simultaneous regulatory submissions for two indications highlight our confidence in depemokimab to help reduce the burden of both asthma and CRSwNP for patients and health systems. Our SWIFT and ANCHOR trials support depemokimab’s potential to suppress IL-5, a known driver of type 2 inflammation, to offer patients sustained inhibition of a key driver of their disease with just two doses per year.”
Depemokimab, a monoclonal antibody that targets interleukin-5 (IL-5), is the first ultra-long-acting biologic to be evaluated in phase III trials and be accepted for regulatory review for use in these conditions. Depemokimab's extended half-life, high-binding affinity and potency, support six month (26 week) dosing regimens based on results from the SWIFT and ANCHOR trials. In asthma patients and patients with CRSwNP, these trials showed depemokimab could offer sustained inhibition of a key driver of their disease, and help achieve key clinical outcomes with a dosing schedule of just two injections per year. Longer intervals between doses have been shown to overcome barriers to optimal care such as patient adherence.
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 hospitalisation. Type 2 inflammation is also present in up to 80% of people with CRSwNP and is associated with more severe disease and symptoms.
In Europe, more than 42 million people are estimated to have asthma, which contributes to the significant burden this condition has on the lives of patients and healthcare resources, with an estimated annual societal cost of 46 billion euros. CRSwNP is a chronic condition that affects up to 4% of the general population, of whom 40% have uncontrolled disease.
SWIFT-1 and SWIFT-2 were replicate 52-week, randomised (2:1), double-blind, placebo-controlled, parallel-group, multi-centre Phase III clinical trials. The trials assessed the efficacy and safety of depemokimab adjunctive therapy in 382 and 380 adult and adolescent participants with asthma with type 2 inflammation characterised by blood eosinophil count, who were randomised to receive depemokimab or placebo respectively, in addition to their standard of care treatment with medium to high-dose inhaled corticosteroids plus at least one additional controller. Number of subjects included in the Full Analysis of SWIFT-1: depemokimab = 250, placebo = 132 and in SWIFT-2: depemokimab = 252, placebo = 128. These results have been reported and published in the New England Journal of Medicine.
See citation- Jackson DJ, Wechsler ME, et al. Twice-Yearly Depemokimab in Severe Asthma with an Eosinophilic Phenotype. N Engl J Med. 2024, 391:2337 doi: 10.1056/NEJMoa2406673. PMID: 39248309
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