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The UK’s medicines regulator has approved GSK’s twice-yearly medicine Exdensur as an add-on treatment for asthma in patients aged 12 and older, and for a chronic inflammatory sinus condition in adults.
First approval for Exdensur, administered once every six months
Branded as Exdensur, the treatment is given as an injection under the skin once every six months. The UK authorisation marks the first approval for the drug.
Who the approval applies to
The medicine is approved for patients whose symptoms remain inadequately controlled despite standard-of-care treatment. In chronic rhinosinusitis with nasal polyps—non-cancerous growths—this includes cases where patients have also undergone surgery.
US review ongoing, decision expected December 16
Exdensur is also being reviewed by the U.S. Food and Drug Administration (FDA), with a decision expected by December 16.
How the drug works: targeting interleukin-5 to reduce eosinophil-driven inflammation
Asthma causes swelling in the airways of the lungs, making breathing difficult. Severe chronic rhinosinusitis involves inflammation of the nose and paranasal sinuses, with symptoms persisting for more than 12 weeks.
Exdensur targets interleukin‑5, an immune signalling protein, aiming to lower eosinophil‑driven inflammation—when excess white blood cells accumulate in the airways and worsen asthma symptoms. By reducing this inflammation, the treatment is intended to help patients breathe more easily and reduce flare-ups.
Related links: Illustration shows GSK (GlaxoSmithKline) logo; GSK (GSK.L); The Thomson Reuters Trust Principles.
