GSK’s Exdensur receives MHRA approval for asthma and rhinosinusitis
Esme Needham | December 16, 2025 | News story | Regulatory Affairs, Research and Development | Asthma & COPD, GSK
GSK’s Exdensur (depemokimab), a twice-yearly biological medicine, has received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for use as an add-on treatment for asthma in adults and adolescents aged 12 and over, and as an add-on treatment for severe chronic rhinosinusitis with nasal polyps (CRSwNP) in adults.
Exdensur has been approved for patients with these conditions whose symptoms remain inadequately controlled by standard of care treatments, including surgery in the case of CRSwNP.
Asthma is a condition where inflammation and narrowing of airways in the lungs makes breathing difficult. Severe chronic rhinosinusitis is a condition where inflammation of the nose and paranasal sinuses persists for over 12 weeks. Inflammation in these areas can lead to soft tissue growths known as nasal polyps. In both these conditions, Exdensur works by blocking interleukin-5, a protein that drives type 2 inflammation.
Exdensur is administered via injection once every six months, and is the first twice-yearly biological medicine indicated for these conditions. The most common reported side effects include itchy skin, headache, tiredness and injection site reactions.
Julian Beach, interim executive director, Healthcare Quality and Access at the MHRA, 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.”
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