UK approves the first twice yearly biological medicine for asthma and severe chronic rhinosinusitis with nasal polyps
As with any medicine, the MHRA will keep the safety and effectiveness of depemokimab under close review.
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (15 December 2025) approved depemokimab (Exdensur), 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.
Asthma is a condition that inflames and narrows the airways in the lungs making breathing difficult, while severe chronic rhinosinusitis is inflammation of the nose and paranasal sinuses where symptoms persist for more than 12 weeks. This inflammation can lead to soft tissue growths, known as nasal polyps.
In patients with these conditions, the active ingredient, depemokimab, works by blocking a key protein (interleukin-5) and reducing type 2 inflammation that plays a major role in both asthma and CRSwNP.
The medicine is administered via injection under the skin once every six months.
Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access, said
These conditions affect a significant number of people across the UK, and in some cases can be difficult to manage despite existing treatments.
This approval represents another potential treatment option for patients living with some forms of these conditions whose symptoms have not been adequately controlled with current therapies.
As with all licensed medicines, we will keep the safety and effectiveness of depemokimab under close review.
The most common side effects of the medicine (which may affect more than 1 in 10 people) include itchy skin, headache, tiredness, and injection site reactions. A full list of side effects can be found in the Patient Information Leaflet (PIL) or the Summary of Product Characteristics (SmPC), which will be published on the MHRA website within 7 days of approval.
Anyone who suspects they’re having a side effect from this medicine is encouraged to talk to their doctor, pharmacist, or nurse and report it directly to the Yellow Card scheme, either through the website https://yellowcard.mhra.gov.uk or by searching the Google Play or Apple App stores for MHRA Yellow Card.
Notes to editors
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The new marketing authorisation was granted on 15 December 2025 to GSK plc.
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Depemokimab was submitted and approved via the MHRA’s national assessment procedure.
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More information can be found in the Summary of Product Characteristics and Patient Information leaflets which will be published on the MHRA Products website within 7 days of approval.
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The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
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The MHRA is an executive agency of the Department of Health and Social Care.
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For media enquiries, please contact the newscentre@mhra.gov.uk, or call on 020 3080 7651.