GSK’s Depemokimab applications accepted for asthma with type 2 inflammation and for chronic rhinosinusitis with nasal polyps

GSK has recently announced that the US FDA has accepted for review the Biologics License Application for the use of depemokimab in two indications.

Note that the proposed indications are as add-on maintenance treatment of asthma in adult and pediatric patients aged 12 years and older with type 2 inflammation characterised by an eosinophilic phenotype on medium- to high-dose inhaled corticosteroids plus another asthma controller and, as add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyps.

Kaivan Khavandi, SVP and Global Head, Respiratory, Immunology & Inflammation R&D, GSK, 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 interleukin-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 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 patients with asthma with type 2 inflammation and patients with CRSwNP, these trials met their primary endpoints, showing that 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.

 

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Related Topics and Keywords

depemokimab, type 2 inflammation and for chronic rhinosinusitis with nasal polyps