GSK: FDA to review asthma application
(CercleFinance.com) - GSK has announced that the US FDA has agreed to review the Biologics License Application for the use of depemokimab in two asthma indications.
The proposed indications are as adjunctive maintenance treatment of asthma in adult and pediatric patients aged 12 and over with type 2 inflammation characterized by an eosinophilic phenotype on medium- to high-dose inhaled corticosteroids (ICS) and another asthma controller, and as adjunctive maintenance treatment in adult patients with chronic rhinosinusitis with inadequately controlled nasal polyps.
At present, depemokimab is not approved for use in any country.
GSK said that their ur SWIFT and ANCHOR trials support the potential of depemokimab to suppress interleukin-5 (IL-5), a known driver of type 2 inflammation, to offer patients sustained inhibition of a key factor in their disease with just two doses per year.
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The proposed indications are as adjunctive maintenance treatment of asthma in adult and pediatric patients aged 12 and over with type 2 inflammation characterized by an eosinophilic phenotype on medium- to high-dose inhaled corticosteroids (ICS) and another asthma controller, and as adjunctive maintenance treatment in adult patients with chronic rhinosinusitis with inadequately controlled nasal polyps.
At present, depemokimab is not approved for use in any country.
GSK said that their ur SWIFT and ANCHOR trials support the potential of depemokimab to suppress interleukin-5 (IL-5), a known driver of type 2 inflammation, to offer patients sustained inhibition of a key factor in their disease with just two doses per year.
Copyright (c) 2025 CercleFinance.com. All rights reserved.