The Medicines and Healthcare products Regulatory Agency 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.
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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