GSK PLC on Monday said Exdensur has been approved in the UK, for the treatment of asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps.
The London-based pharmaceuticals firm said the marketing approval by the UK’s Medicines & Healthcare Products Regulatory Agency is based on data from the Swift and Anchor phase 3 trials.
These showed sustained efficacy with a twice-yearly dosing regimen for Exdensur.
Exdensur is the brand name for the prescription medicine with the active substance depemokimab.
‘Each of the four trials met their primary or co-primary endpoints with statistically significant and clinically meaningful results, comparing the addition of depemokimab to standard of care versus standard of care alone,’ GSK said.
Across the trials, depemokimab was well-tolerated, with patients experiencing a similar rate and severity of side effects as those receiving placebo.
Depemokimab recently received a positive Committee for Medicinal Products for Human Use opinion in the EU, and it is currently under regulatory review in other countries, including in the US, Japan and China. Decisions on these approvals are expected to begin in December 2025 and continue through the first half of 2026.
GSK closed up 0.6% at 1,835.50 pence each in London on Monday.
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