28th Jan 2025 09:10
(Alliance News) - GSK PLC on Tuesday said applications for its treatment for a type of asthma and chronic rhinosinusitis with nasal polyps, or CRSwNP, have been accepted for review in China, Japan and the EU.
The London-based pharmaceutical and biotechnology firm said it submitted new drug applications to the China National Medical Products Administration and the Japanese Ministry of Health, Labour & Welfare, alongside its submission of a marketing authorisation application for the drug to the European Medicines Agency.
The applications were for the use of depemokimab in adult and adolescent patients with asthma with type 2 inflammation, and as an add-on treatment for adult patients with inadequately controlled CRSwNP.
CRSwNP is a chronic inflammatory sinus disease, with 80% of patients showing evidence of the type 2 airway inflammation associated with more severe diseases and symptoms.
Depemokimab is not currently approved anywhere as a treatment, though its extended half-life, high potency and high-binding affinity for IL-5 means it could potentially provide sustained inhibition of inflammatory functions in patients, with dosing once every six months.
GSK Global Head of Respiratory/Immunology Reseearch & Development Kaivan Khavandi 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."
Shares in GSK were up 0.1% at 1,404.00 pence each in London on Tuesday morning.
By Emily Parsons, Alliance News reporter
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