Nemluvio (Nemolizumab) for Prurigo Nodularis: 5 Facts About This First-in-Class Biologic
Key takeaways:
In August 2024, the FDA approved Nemluvio (nemolizumab), a new injectable medication for prurigo nodularis (PN) in adults. PN is a chronic skin condition that causes itchy, raised bumps or nodules.
Nemluvio is the first medication of its kind, targeting interleukin-31 (IL-31). IL-31 is a protein involved in itching and inflammation.
Nemluvio is administered as a subcutaneous (under the skin) injection. With training, you (or a caregiver) may be able to inject Nemluvio at home.
In December 2024, the FDA also approved Nemluvio for people ages 12 and older with moderate-to-severe atopic dermatitis (eczema).
Prurigo nodularis (PN) is a skin condition that can significantly impact your daily life. Its main symptom, intense itching, can lead to sleepless nights and frequent scratching — which can make things worse. Traditional treatments don’t always work well enough for everyone. This can leave many people without adequate relief.
In August 2024, the FDA approved Nemluvio (nemolizumab), a first-in-class biologic that targets an underlying pathway driving PN symptoms. Unlike pills or creams, biologics — medications produced using living systems — work in a more precise way to treat health conditions at their source.
Below are five key facts about Nemluvio, how it works, and its potential applications.
1. Nemluvio provides targeted relief for prurigo nodularis
Nemluvio is a monoclonal antibody, a type of biologic designed to target specific parts of the immune system. While oral pills often affect the whole body, monoclonal antibodies like Nemluvio focus on a particular pathway.
In PN, Nemluvio blocks the signaling of interleukin-31 (IL-31). IL-31 is a protein that triggers intense itching and skin inflammation, among other effects. By blocking IL-31, Nemluvio helps reduce the urge to scratch. This can, in turn, prevent the development of new nodules (bumps). In this way, it’s designed to break the vicious “itch-scratch-itch” cycle that drives PN.
2. Nemluvio works differently from other medications for prurigo nodularis
PN is often treated with topical steroids or oral medications, such as antihistamines, to manage symptoms. As described above, Nemluvio works differently by directly targeting a key driver of itching and inflammation.
Nemluvio also works differently from Dupixent (dupilumab), another biologic for PN. Dupixent blocks IL-4 and IL-13, which are linked to IL-31. Nemluvio, on the other hand, targets IL-31 directly. Both medications can be effective, although they haven’t been directly compared in studies. But Nemluvio’s direct action on IL-31 offers a slightly more targeted approach to managing itch.
3. Nemluvio can help reduce itching, heal skin, and improve sleep
Nemluvio was studied in adults with moderate-to-severe PN. Clinical trial results have shown that it can significantly reduce itching and promote nodule healing. This can lead to improved quality of life, including better sleep. Nemluvio also works quickly, with itch relief starting within 48 hours of treatment.
Reduces itching: Up to 56% of people receiving Nemluvio had a significant reduction in itch severity after 16 weeks compared to placebo (injection without medication). And 41% had significant improvements as early as week 4.
Heals skin: Up to 38% of people receiving Nemluvio had cleared all or most of their skin nodules at 16 weeks.
Improves sleep: Intense itching can cause sleeping problems in people living with PN. About half of people receiving Nemluvio had significantly improved sleep at 16 weeks.
Prurigo nodularis medications: Nemluvio is the newest treatment available for prurigo nodularis. Here’s an overview of the medications used to treat the condition.
Out with the old: If you’re taking a newer medication, it might be a biologic. Discover the differences between biologics and small molecule drugs.
Got the itch for knowledge? Learn about common causes of itchy skin.
4. After proper training, you may be able to administer Nemluvio at home
Nemluvio is given as a subcutaneous (under the skin) injection every 4 weeks. It comes in a prefilled injection pen with two chambers. One chamber contains the medication powder and the other contains sterile water. Before injecting, the two components need to be mixed by activating the pen. You turn a knob on the device to do this; no need to do any outside mixing on your own (aside from shaking the pen).
After receiving training, you or a caregiver can administer Nemluvio at home. The injection can be given in your abdomen, front of the thigh, or upper arm. If you choose the upper arm, someone else should give you the injection.
Your healthcare team will guide you through the steps to ensure you feel confident using Nemluvio safely at home.
5. Nemluvio is also approved for moderate-to-severe atopic dermatitis
Nemluvio isn’t just for PN. It was also recently approved as a treatment for moderate-to-severe atopic dermatitis (eczema) in adults and adolescents age 12 and older. Like PN, eczema involves intense itching and skin inflammation, which are also linked to IL-31.
In clinical trials, people with eczema who received Nemluvio saw significant improvements in itching, skin appearance, and sleep when used alongside topical treatments.
The bottom line
Nemluvio (nemolizumab) is a new type of medication for prurigo nodularis (PN). It offers targeted relief by addressing a key driver of symptoms. It has been shown to help reduce itching, heal skin nodules, and improve sleep in clinical trials.
If you’re living with PN and haven’t found relief with current treatments, talk to your dermatologist to see if Nemluvio might be right for you.
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References
Bağci, I. S., et al. (2018). IL-31: A new key player in dermatology and beyond. The Journal of Allergy and Clinical Immunology.
Bewley, A., et al. (2022). Prurigo nodularis: A review of IL-31RA blockade and other potential treatments. Dermatology and Therapy.
Galderma. (2024). Galderma receives U.S. FDA approval for Nemluvio (nemolizumab) for adult patients living with prurigo nodularis.
Galderma Laboratories. (2024). Nemluvio - nemolizumab-ilto injection, powder, lyophilized, for solution [package insert]. DailyMed.
Joel, M. Z., et al. (2023). Risk of incident sleep disorders in patients with prurigo nodularis: A population-level analysis using The Health Improvement Network. Journal of the American Academy of Dermatology.
Kwatra, S. G., et al. (2023). Phase 3 trial of nemolizumab in patients with prurigo nodularis. The New England Journal of Medicine.
Ludmann, P. (2021). Prurigo nodularis: Overview. American Academy of Dermatology Association.
National Eczema Association. (2024). Galderma receives U.S. FDA approval for Nemluvio® (nemolizumab) for patients with moderate-to-severe atopic dermatitis.
Orfali, R. L., et al. (2023). Blockage of the IL-31 pathway as a potential target therapy for atopic dermatitis. Pharmaceutics.
Silverberg, J. I., et al. (2024). Nemolizumab with concomitant topical therapy in adolescents and adults with moderate-to-severe atopic dermatitis (ARCADIA 1 and ARCADIA 2): Results from two replicate, double-blind, randomised controlled phase 3 trials. The Lancet.
Ständer, S., et al. (2022). Nemolizumab efficacy in prurigo nodularis: Onset of action on itch and sleep disturbances. Journal of the European Academy of Dermatology and Venereology.
U.S. Food and Drug Administration. (2024). Drug trials snapshots: Nemluvio.
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