MHRA approves GSK’s Exdensur
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved pharma major GSK’s (LSE: GSK) Exdensur (depemokimab), the first twice-yearly biological medicine for use as an add-on treatment for asthma in adults and adolescents aged 12 years and older, and as an add-on treatment for severe chronic rhinosinusitis with nasal polyps (CRSwNP) in adults.
Depemokimab has been approved, via the MHRA’s national assessment procedure, for patients with these conditions whose symptoms remain inadequately controlled despite treatment with standard of care, including surgery in the case of CRSwNP. Depemokimab recently received a positive opinion in the European Union and it is currently under regulatory review in other countries, including in the USA, Japan and China. Decisions on these approvals are expected starting in December 2025 and continuing through first-half 2026.
GlobalData’s consensus forecasts project depemokimab’s global sales to reach $1.65 billion by 2031.
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