Dec. 17, 2024 -- The FDA last week approved Nemluvio for treating moderate to severe atopic dermatitis, a type of eczema, in people aged 12 or older. Nemluvio is to be used with topical corticosteroids or calcineurin inhibitors when topical therapies alone don’t manage the disease well.
Atopic dermatitis is a long-term skin condition that affects about 7% of people in the U.S. and about 230 million globally. It causes inflammation, irritation, and persistent itching, often with recurring skin rashes or lesions that can ooze, crust over, and harden. Special proteins play a key role in triggering these symptoms. The intense itching can disrupt sleep and significantly impact daily life. Although some current treatments can help, many patients still struggle to achieve clear skin and complete relief from itching.
Nemluvio (nemolizumab) was originally approved in August 2024 for treating prurigo nodularis (hard, itchy bumps on the skin). It is a monoclonal antibody that works by activating the body’s immune system to fight disease. According to a press release from Galderma, the maker of the drug, Nemluvio blocks IL-31 signals, thereby relieving symptoms. It is available for injection in a prefilled pen that patients or their caregivers can learn to use with some training.
The approval is based on positive results from a large clinical trial involving 1,728 patients aged 12 and older with moderate-to-severe atopic dermatitis. Results showed that patients who received Nemluvio, given as an injection every four weeks along with topical corticosteroids and/or calcineurin inhibitors, had significantly improved skin clearance compared with those who received a placebo. Nemluvio was well-tolerated, with a safety profile like that of the placebo group.
Galderma lists the most common side effects of Nemluvio when used for treating atopic dermatitis as headache, muscle and joint pain, and hives (itchy red rashes). The company advises patients to inform their doctor about any medical conditions, especially if they are pregnant or planning to get pregnant, breastfeeding, or scheduled for vaccination, before starting treatment. Also, patients must notify their doctor about all medications, including prescription and over-the-counter drugs, vitamins, and herbal supplements, that they are taking.
