EMA Accepts GSK's Depemokimab for Review in Asthma and CRSwNP
核心洞察
The European Medicines Agency (EMA) has accepted GSK's application for depemokimab as an add-on treatment for asthma (搜索) and chronic rhinosinusitis with nasal polyps (搜索) (CRSwNP (搜索)).
Depemokimab, a monoclonal antibody targeting IL-5 (搜索), could become the first ultra-long-acting biologic with a six-month dosing schedule if approved.
Regulatory submissions are supported by positive results from the SWIFT and ANCHOR trials, demonstrating reduced exacerbations and polyp size, respectively.
The European Medicines Agency (EMA) has accepted for review GSK's Marketing Authorisation Application (MAA) for depemokimab, a novel treatment for asthma (搜索) with type 2 inflammation and chronic rhinosinusitis with nasal polyps (搜索) (CRSwNP (搜索)). The decision marks a significant step toward potentially providing a new therapeutic option for patients with these respiratory conditions.
If approved, depemokimab would be the first ultra-long-acting biologic, administered just twice a year, offering a more convenient dosing schedule compared to existing treatments. The submissions are based on data from the Phase III SWIFT and ANCHOR trials, which demonstrated the efficacy and safety of depemokimab in asthma (搜索) and CRSwNP (搜索), respectively.
Clinical Trial Data
The SWIFT-1 and SWIFT-2 trials evaluated depemokimab as an add-on therapy in adult and adolescent patients (12 years and older) with asthma (搜索) characterized by type 2 inflammation and an eosinophilic phenotype, who were inadequately controlled on medium-to-high dose corticosteroids plus another asthma controller. Results showed that depemokimab significantly reduced exacerbation and hospitalization rates in these patients.
The ANCHOR-1 and ANCHOR-2 trials assessed depemokimab as an add-on therapy in adult patients with inadequately controlled CRSwNP (搜索). Data from these trials indicated that depemokimab reduced nasal polyp size and nasal obstruction compared to placebo.
Kaivan Khavandi, SVP, Global Head of Respiratory/Immunology R&D at GSK, stated, "Simultaneous regulatory submissions for two indications highlight our confidence in depemokimab to help reduce the burden of both asthma (搜索) and CRSwNP (搜索) for patients and health systems. Our SWIFT and ANCHOR trials support depemokimab's potential to suppress IL-5 (搜索), 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."
Mechanism of Action
Depemokimab is a monoclonal antibody that targets interleukin-5 (IL-5 (搜索)), a key cytokine in type 2 inflammation. Type 2 inflammation, often identified by elevated blood eosinophil counts, is a significant driver in many diseases, including asthma (搜索) and CRSwNP (搜索). In asthma, type 2 inflammation can lead to exacerbations and hospitalizations, while in CRSwNP, it is associated with more severe disease and symptoms. By inhibiting IL-5, depemokimab aims to reduce inflammation and improve clinical outcomes.
Disease Burden
Asthma (搜索) affects more than 42 million people in Europe, contributing to a substantial economic burden estimated at 46 billion euros annually. CRSwNP (搜索), a chronic condition, affects up to 4% of the general population, with 40% experiencing uncontrolled disease.
Ongoing Development Program
Beyond asthma (搜索) and CRSwNP (搜索), depemokimab is being evaluated in Phase III trials for other IL-5 (搜索) mediated diseases, including eosinophilic granulomatosis with polyangiitis (搜索) (EGPA (搜索)) and hypereosinophilic syndrome (搜索) (HES (搜索)).