GSK PLC on Friday said the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended the approval of depemokimab in two indications.
The London-based pharmaceutical company said one recommended approval is as add-on maintenance treatment for severe asthma with type-2 inflammation characterised by blood eosinophil count in adults and adolescents 12 years and older who are inadequately controlled despite high dose inhaled corticosteroids, ICS, plus another asthma controller.
The other recommended approval is as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe asthma and chronic rhinosinusitis with nasal polyps for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control.
The positive opinion is based on four phase-3 trials with statistically significant and clinically meaningful endpoints across severe asthma and chronic rhinosinusitis with nasal polyps, GSK said.
Depemokimab is an ultra-long-acting biologic, which is a medicine derived from living organisms.
Further, GSK noted that the CHMP recommended the approval of Nucala for the treatment of chronic obstructive pulmonary disease.
The recommendation is for the monoclonal antibody to be used in adults as an add-on maintenance treatment for uncontrolled chronic obstructive pulmonary disease characterised by raised blood eosinophils on a combination of an inhaled corticosteroid, ICS, a long-acting beta2-agonist, LABA, and a long-acting muscarinic antagonist, LAMA.
Kaivan Khavandi, SVP & Global Head, Respiratory, Immunology & Inflammation research & development at GSK said: ‘People living with uncontrolled COPD with an eosinophilic phenotype continue to experience exacerbations that can lead to irreversible lung damage and avoidable hospitalisations and emergency department visits. Preventing these events is crucial to slowing the progression of disease and today’s CHMP recommendation brings us closer to providing Nucala to patients who are in need of new options.’
GSK expects the European Commission to decide on approvals for both depemokimab and Nucala in the first quarter of 2026.
GSK shares were 0.1% higher at 1,822.50 pence each on Friday afternoon in London.
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