Galderma’s dermatology monoclonal antibody (mAb) Nemluvio (nemolizumab) has shown proof of improving symptoms of atopic dermatitis (AD) and prurigo nodularis in as little as 48 hours.

In post-hoc analysis of the Phase III ARCADIA (NCT03985943 and NCT03989349) and OLYMPIA (NCT04501666 and NCT04501679) trials, Nemluvio reduced itchiness in AD patients by 10.7% after 48 hours compared to 2.9% placebo, and by 17.2% in patients with prurigo nodularis compared to 3.7% in placebo. 

The data, which has also been published in the Journal of the European Academy of Dermatology and Venereology, also showed improved sleep disturbance in 9.9% of AD patients and 13.4% of prurigo nodularis patients, compared to 4.6% and 4.3% in each placebo cohort, respectively.

After 14 days, 25% of patients with AD and more than a third of patients with prurigo nodularis achieved significant and clinically meaningful responses in both itch and sleep outcomes.

Dr Christophe Piketty, author and global programme head of dermatology at Galderma, said: “These new data reinforce our understanding of Nemluvio’s rapid onset of action in relieving itch and, in turn, improving sleep in patients living with AD and prurigo nodularis, as well as its role in targeting the IL-31 pathway.” 

Nemluvio is the first approved monoclonal antibody that specifically targets interleukin (IL)-31 receptor alpha, inhibiting the signalling of IL-31.

The drug gained approval from the US Food and Drug Administration (FDA) in August 2024 for prurigo nodularis. In December 2024, the drug label was expanded for use in moderate-to-severe AD in patients aged 12 and older. 

Nemluvio generated sales of $23m in 2024, higher than Galderma’s expectations. GlobalData’s patient-based forecast predicts the mAb to reach blockbuster status in 2030 and generate $1.6bn in sales in AD in 2033.

Overall, the AD market across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan) is set to reach $22.4bn in 2033, GlobalData analysts conclude, with IL inhibitors being a significant contributor in the market, as well as Janus kinase (JAK) inhibitors.

GlobalData is the parent company of Clinical Trials Arena.

AD and prurigo nodularis are debilitating skin conditions that significantly affect quality of life, with symptoms such as persistent itch, skin lesions and poor sleep quality.