GSK (GSK) said Tuesday that regulators in Europe, Japan and China have accepted separate applications to review its depemokimab drug candidate for a pair of asthma indications, including as an add-on treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyps.
The company said it is also seeking approval to market the monoclonal antibody as a maintenance add-on therapy for type 2 inflammation with an eosinophilic phenotype in patients aged 12 and up whose asthma is inadequately controlled by corticosteroids.
GSK said that if approved, depemokimab will be the first ultra-long-acting biologic with six-month dosing and that it is not currently approved in any jurisdiction.
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