FDA Begins Review of Depemokimab for Type 2 Asthma and CRSwNP

London, UK -- 03 March 2025 -- GSK plc has revealed that the US Food and Drug Administration (FDA) has accepted its Biologics License Application for the drug depemokimab, intended for two specific uses. This drug is under consideration as an additional maintenance therapy for asthma in both adults and children aged 12 and over, particularly those with type 2 inflammation marked by an eosinophilic phenotype, who are already on medium- to high-dose inhaled corticosteroids plus an additional asthma controller. Additionally, depemokimab is being reviewed for use in adults suffering from chronic rhinosinusitis with nasal polyps (CRSwNP) that are inadequately managed.

The FDA has set the Prescription Drug User Fee Act (PDUFA) target date for 16 December 2025. Kaivan Khavandi, Senior Vice President and Global Head of Respiratory, Immunology & Inflammation Research and Development at GSK, emphasized that submitting depemokimab for review for these two indications demonstrates the company's belief in its potential to alleviate the challenges posed by asthma and CRSwNP. The SWIFT and ANCHOR clinical trials indicate that depemokimab can inhibit interleukin-5 (IL-5), a core component of type 2 inflammation, promising sustained relief with only two doses annually.

Depemokimab distinguishes itself as the first ultra-long-acting biologic to be tested in phase III trials and accepted for FDA review for these conditions. The drug's extended half-life and strong binding affinity enable a biannual dosing schedule, as supported by the SWIFT and ANCHOR trial results. These studies met their primary goals, illustrating that depemokimab could provide continuous suppression of significant disease drivers with a mere two injections per year. Such an extended dosing interval could improve patient adherence, a common hurdle in chronic disease management.

IL-5 is pivotal in type 2 inflammation, which is typically identified by blood eosinophil count and contributes to various diseases. The majority of patients with difficult-to-manage asthma exhibit type 2 inflammation, which often results in exacerbations and hospital visits. This type of inflammation also affects up to 85% of individuals with CRSwNP, leading to more severe symptoms. In the United States alone, asthma affects over 26 million people, with 40% experiencing at least one attack annually, thereby placing a considerable burden on healthcare systems.

CRSwNP afflicts 2.1% of the US population, with up to 30% having nasal polyps. The symptoms of CRSwNP, such as nasal obstruction, loss of smell, and facial pain, can substantially impact quality of life, akin to other chronic diseases like COPD and diabetes.

Depemokimab is yet to receive approval for any application worldwide. Its phase III asthma program includes the SWIFT-1 and SWIFT-2 trials, complemented by an open-label extension study, AGILE. An additional study, NIMBLE, is examining the outcomes of switching asthma patients with type 2 inflammation from existing treatments like mepolizumab or benralizumab to depemokimab. The CRSwNP phase III program comprises ANCHOR-1 and ANCHOR-2 studies.

The trials SWIFT-1 and SWIFT-2 were 52-week, randomized, double-blind, placebo-controlled studies assessing depemokimab's effectiveness and safety as an adjunct therapy in severe asthma patients. Meanwhile, ANCHOR-1 and ANCHOR-2 evaluated depemokimab as an add-on treatment for adult CRSwNP patients over a similar timeframe. Both sets of trials met their primary endpoints and reported comparable adverse event incidences between depemokimab and placebo groups. The full results of these studies were presented at a joint congress and published in a leading medical journal.

GSK continues to forge ahead in respiratory medicine, aiming to redefine treatment goals and improve outcomes for millions suffering from various respiratory diseases. With its extensive portfolio and research pipeline, GSK remains committed to advancing the understanding and management of both common and rare respiratory conditions.