GSK plc (LON: GSK, NYSE: GSK) announced that the US Food and Drug Administration (FDA) has accepted indication approval filings for its depemokimab, a monoclonal antibody (mAb) targeting IL-5, with a PDUFA target date set for December 16, 2025. The UK-based pharmaceutical giant is seeking FDA approval for the drug’s use as an add-on maintenance treatment for asthma in adult and pediatric patients aged 12 years and older with type 2 inflammation characterized by an eosinophilic phenotype on medium-to high-dose inhaled corticosteroids (ICS) plus another asthma controller. Additionally, GSK is seeking approval for depemokimab as an add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).
Drug Profile
Depemokimab, the first ultra-long-acting biologic evaluated in Phase III trials and accepted for regulatory review for use in these conditions, has the potential to become the first ultra-long-acting biologic with a 6-month dosing schedule if approved. This would mark a significant advancement in the treatment of asthma and CRSwNP, offering patients a more convenient and long-lasting therapeutic option.-Fineline Info & Tech
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