FDA Approves Nemluvio for Atopic Dermatitis

The FDA has approved Galderma’s Nemluvio (nemolizumab) for the treatment of patients age 12 and older with moderate to severe atopic dermatitis, according to the details of a recently published news release. Nemluvio should be used in combination with topical corticosteroids and/or calcineurin inhibitors. This is the second FDA-approved indication for Nemluvio. It was first approved in Aug. 2024 as a subcutaneous injection to treat adults with prurigo nodularis.

Atopic dermatitis is a chronic, inflammatory skin disease that manifests as recurrent skin lesions caused by persistent itch, which is the most common symptom reported by 87% of patients. Sleep quality may be affected as a result. It is a heterogenous disease and can be triggered by mental health conditions such as anxiety, usually appearing in childhood. The chance of developing it is higher if there is a family history of hay fever or asthma. Atopic dermatitis currently affects about 230 million people worldwide, including 7% of the United States population.

Nemluvio is the first FDA-approved monoclonal antibody that targets IL-31 receptor alpha, a neuroimmune cytokine that influences functions like itch and inflammation.

This approval is based on the results of the phase 3 ARCADIA clinical trial program, which measured the safety and efficacy of Nemluvio used in combination with background topical corticosteroids, with or without calcineurin inhibitors in 1,728 patients ages 12 and older. Patients were either given placebo or a 30 mg subcutaneous injection of Nemluvio every four weeks. Using the Eczema Area and Severity Index, investigators determined there was a 75% reduction in symptoms after 16 weeks of treatment with Nemluvio, when compared with placebo. Clinically significant responses to itch reduction were seen as early as Week 1. Adverse reactions were limited with 5% of patients reporting headache, 1% reporting joint pain and 1% reporting urticaria.

Nemluvio must be refrigerated and brought to room temperature prior to use. The initial dose of Nemluvio is a 60 mg injection, followed by a 30 mg injection every four weeks. After 16 weeks of treatment, patients can switch to 30 mg every eight weeks. When symptoms improve, topical treatments can be discontinued.

The wholesale acquisition cost for Nemluvio is $4,240 for one prefilled 30 mg pen.