The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised depemokimab (Exdensur) as the UK’s first twice‑yearly biological medicine. The licence covers add‑on treatment for asthma in adults and adolescents aged 12 years and over, and add‑on treatment for severe chronic rhinosinusitis with nasal polyps in adults. The decision was issued on 15 December 2025.
MHRA states the authorisation was granted via its national assessment procedure for patients whose symptoms remain inadequately controlled despite standard care, including surgery for CRSwNP. Exdensur is administered as a subcutaneous injection once every six months.
According to the agency, depemokimab works by blocking interleukin‑5 and reducing type 2 inflammation, mechanisms implicated in both asthma and CRSwNP.
The regulator lists itchy skin, headache, tiredness and injection‑site reactions as the most common adverse effects. A Patient Information Leaflet and Summary of Product Characteristics will be posted on the MHRA Products website within seven days of approval; suspected side effects should continue to be reported to the Yellow Card scheme. MHRA also notes it will keep the medicine’s safety and effectiveness under review.
For context, MHRA’s national assessment procedure is the UK route for marketing authorisations. Guidance indicates an innovative medicine can receive a decision within 150 clock‑on days if issues are resolved, and within 210 days otherwise. The regulator aims to align its decisions with NICE to accelerate access, and publishes a UK Public Assessment Report-within around 30 days for new active substances.
NICE has an appraisal in development for depemokimab in severe eosinophilic asthma in people aged 12 years and over, with an expected publication date of 25 March 2026. NICE’s CRSwNP project page confirms that evaluation is currently suspended after the company indicated it would not submit evidence at this stage.
At EU level, the EMA’s Committee for Medicinal Products for Human Use adopted a positive opinion for Exdensur on 11 December 2025 for severe eosinophilic asthma and CRSwNP; the European Commission decision remains pending. Reuters reports that the UK authorisation is the first worldwide, while GSK has indicated the US FDA review is scheduled to conclude on 16 December 2025.
Policy Wire analysis: six‑monthly subcutaneous dosing implies fewer injection appointments than many existing biologics and may shape clinic scheduling once product specifics are confirmed. Final initiation criteria, dosing instructions and monitoring should be taken from the UK SmPC when published and from subsequent NICE guidance.