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MHRA Approves Depemokimab: A New Option for Asthma and CRSwNP

Date of Approval: 15 December 2025

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced the approval of depemokimab (marketed as Exdensur). This groundbreaking biological medicine is the first of its kind to be administered biannually and is intended as an add-on treatment for adults and adolescents aged 12 years and older suffering from asthma. It also serves as an adjunct therapy for adults with severe chronic rhinosinusitis with nasal polyps (CRSwNP).

New Treatment for Patients with Persistent Symptoms

Depemokimab has received approval through the MHRA’s rigorous national assessment procedure specifically for patients facing these conditions whose symptoms have not been adequately managed with standard treatments. This includes those who have undergone surgical interventions for CRSwNP without satisfactory results.

Asthma is characterized by the inflammation and constriction of the airways, leading to difficulty in breathing. Meanwhile, severe chronic rhinosinusitis involves long-lasting inflammation in the nose and paranasal sinuses, typically persisting for over 12 weeks. This ongoing inflammation can result in the formation of growths known as nasal polyps.

Mechanism of Action

The therapeutic efficacy of depemokimab lies in its ability to inhibit a critical protein known as interleukin-5. By doing so, it reduces type 2 inflammation, which is instrumental in the pathological processes of both asthma and CRSwNP.

The administration is simple: the medication is delivered via a subcutaneous injection once every six months, easing the treatment burden on patients.

Perspective from MHRA

Julian Beach, MHRA’s Interim Executive Director for Healthcare Quality and Access, commented on the significance of this approval:

"These conditions impact a substantial number of individuals across the UK, and managing them can sometimes prove challenging, even with existing therapies. This approval introduces a new potential treatment avenue for patients whose symptoms remain uncontrolled despite current options. We remain committed to closely monitoring the safety and effectiveness of depemokimab, as we do with all licensed medications."

Side Effects and Patient Advisory

As with all pharmaceuticals, depemokimab may come with side effects. The most commonly reported adverse reactions, which could affect more than 1 in 10 patients, include itchy skin, headache, fatigue, and injection site reactions. For comprehensive information on side effects, patients are encouraged to consult the Patient Information Leaflet (PIL) or the Summary of Product Characteristics (SmPC), which will be made available on the MHRA website within the next week.

Individuals who suspect they are experiencing side effects from this medication should promptly consult their healthcare provider—be it a doctor, pharmacist, or nurse. Additionally, concerns or reports can be submitted directly to the Yellow Card scheme, either via their website (Yellow Card) or through mobile apps available on the Google Play or Apple App stores.

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Notes to Editors

• The new marketing authorization for depemokimab was granted on 15 December 2025 to GSK plc.
• The approval was facilitated through the MHRA’s national assessment procedure.
• Additional information will soon be available through the Summary of Product Characteristics and Patient Information Leaflets on the MHRA Products website.
• The MHRA plays a vital role in monitoring all medicines and medical devices in the UK, ensuring their efficacy and safety through comprehensive evaluations grounded in robust evidence to justify the benefits versus risks.
• The MHRA functions as an executive agency under the Department of Health and Social Care.
• For media inquiries, reach out to [email protected] or call 020 3080 7651.

With these advancements, patients now have access to new therapeutic options that could significantly improve their quality of life.

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