MHRA approves first twice‑yearly biologic for asthma
On 15 December 2025, the UK medicines regulator, the MHRA, approved depemokimab, branded Exdensur - the first biological medicine in the UK given just twice a year for certain patients. It can be used as an add‑on for asthma in adults and adolescents aged 12+, and as an add‑on for severe chronic rhinosinusitis with nasal polyps in adults when symptoms remain hard to control.
Approval was granted through the MHRA’s national assessment procedure and is aimed at people whose condition hasn’t settled despite standard treatments. For nasal polyps this includes those who have already tried surgery but still struggle.
If you’re new to these terms, asthma inflames and narrows the airways, making breathing more difficult. Chronic rhinosinusitis is long‑lasting inflammation of the nose and sinuses that persists for more than 12 weeks; in some people, that swelling forms soft growths called nasal polyps which can block breathing and dull your sense of smell.
Depemokimab works by blocking interleukin‑5 (IL‑5), a signalling protein involved in type 2 inflammation. By damping this pathway, the medicine targets a driver of symptoms in some forms of asthma and chronic rhinosinusitis with nasal polyps.
The dosing schedule is straightforward: a subcutaneous injection once every six months, given in addition to your usual medicines. It is not a replacement for your reliever inhaler or other prescribed care, so you and your clinician would agree how it fits into your plan.
Julian Beach, the MHRA’s Interim Executive Director for Healthcare Quality and Access, said the decision adds another option for people whose symptoms stay poorly controlled, and that safety and effectiveness will be kept under close review. That ongoing vigilance is standard for all licensed medicines.
As with all treatments, side effects are possible. The most common, affecting more than one in ten people, were itchy skin, headache, tiredness and reactions where the injection was given. A full list will appear in the Patient Information Leaflet and the Summary of Product Characteristics on the MHRA Products website within seven days of approval.
If you think you’ve had a side effect, speak to a doctor, pharmacist or nurse, and consider reporting it through the MHRA’s Yellow Card scheme at yellowcard.mhra.gov.uk or via the official app stores by searching ‘MHRA Yellow Card’. Sharing your experience helps regulators spot safety patterns early.
Quick explainer: a biological medicine (or biologic) is made using living cells and often targets very specific immune signals. Many biologics are antibodies designed to attach to one protein - here, IL‑5 - to reduce the overactive inflammation that drives disease.
Who is behind it? The marketing authorisation was granted to GSK plc on 15 December 2025. That date matters because it starts the clock for final documents: prescribers and patients can expect the official leaflets to appear within a week, and the MHRA, an executive agency of the Department of Health and Social Care, will continue to weigh benefits against risks.
What this means for you: if you or a pupil in your class lives with severe asthma or stubborn nasal polyps, this does not change care overnight, but it adds a twice‑yearly option to discuss at your next specialist appointment. Bring a record of symptoms and past treatments, and never stop prescribed medicines without medical advice.
Before you share a headline, do a quick media‑literacy check. Exdensur is not a cure and it won’t suit everyone; it is an add‑on for specific patients whose symptoms remain difficult to control. Decisions rest on evidence in the product information and a conversation with a specialist.