This national approval was granted after an Access Consortium new active substance work-sharing initiative (NASWSI) procedure.
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.
Julian 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
The new marketing authorisation was granted on 17 February 2025 to Galderma (U.K.) Limited
This national approval was granted after an Access Consortium new active substance work-sharing initiative (NASWSI) procedure.
