The Medicines and Healthcare products Regulatory Agency (MHRA)
has today, 17 February 2025, approved the medicine
nemolizumab (brand name Nemluvio) for the treatment of two skins
conditions – moderate to severe prurigo nodularis for adults aged
18 and above, and moderate-to-severe atopic dermatitis (eczema)
for adults and adolescents aged 12 and above.
Prurigo nodularis is a chronic skin condition that causes hard,
itchy bumps called nodules. The safety and efficacy of
nemolizumab for this condition were demonstrated in two clinical
trials in adults (aged 18 yrs and over). The safety and efficacy
of nemolizumab have not been established in patients below the
age of 18 years with prurigo nodularis.
Nemolizumab has also been approved for both adults and adolescent
patients (from aged 12 years and with a body weight of at least
30kg) for the treatment of moderate-to-severe atopic dermatitis.
It has been approved for use in combination with therapies used
on the skin (topical) when the atopic dermatitis is not well
controlled by topical therapies alone. Efficacy and safety were
demonstrated in two clinical trials in adolescents and adults
with moderate-to-severe atopic dermatitis which was not
adequately controlled by topical treatments.
Beach, MHRA Interim Executive
Director of Healthcare Quality and Access, said:
“Keeping patients safe and enabling their access to high quality,
safe and effective medical products are key priorities for
us.
“We're assured that the appropriate regulatory standards for the
approval of this medicine have been met. As with all products, we
will keep its safety under close review.”
Nemolizumab's recommended dosage is 30 mg and it is administered
as an injection in a pre-filled pen or pre-filled
syringe.
The most common side effects with Nemluvio in prurigo nodularis
and atopic dermatitis are hypersensitivity and injection site
reactions. For the full list of all side effects reported with
this medicine, see Section 4 of the Patient Information Leaflet
(PIL) or the SmPC available on the MHRA website. As
with any medicine, the MHRA will keep the safety and
effectiveness of nemolizumab's under close review. Anyone who
suspects they are having a side effect from this medicine are
encouraged to talk to their doctor, pharmacist or nurse and
report it directly to the MHRA 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 17 February
2025 to Galderma (U.K.) Limited
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This national approval was granted after an Access Consortium
new active substance work-sharing initiative (NASWSI)
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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The Medicines and Healthcare products Regulatory Agency
(MHRA) is responsible for regulating all medicines and
medical devices in the UK by ensuring they work and are
acceptably safe. All our work is underpinned by robust and
fact-based judgements to ensure that the benefits justify any
risks.
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