Galderma has won approval from the European Commission (EC) for subcutaneous injection Nemluvio (nemolizumab) for the treatment of atopic dermatitis (AD), becoming the latest pharmaceutical company to enter the lucrative market for the skin disorder.
Nemluvio is indicated for patients aged 12 years and older who have moderate-to-severe AD – also known as eczema – and are eligible for systemic therapy. The Swiss drugmaker also announced that the drug has also been approved for prurigo nodularis, another type of chronic skin condition.
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Shares in Galderma rose 0.5% at market open on the Swiss stock exchange following the announcement. The company has a market cap of SFr27bn ($30bn), having gone public in March 2024 in one of the biggest initial public offerings (IPOs) since 2022.
Nemluvio is already approved in the US, gaining the green light from the US Food and Drug Administration (FDA) in August 2024 and December 2024 respectively for prurigo nodularis and AD. Galderma said the injection is also under regulatory review in Canada, Brazil, and South Korea.
The EC based its decision on results from the Phase III ARCADIA and OLYMPIA clinical trial programmes in AD and prurigo nodularis patients respectively. Two ARCADIA trials demonstrated significant improvements in skin clearance after four months of treatment with Nemluvio in combination with background topical corticosteroids. Two trials from the OLYMPIA programme meanwhile showed that Galderma’s therapy was effective in reducing itch and skin lesions.
Galderma’s CEO Flemming Ørnskov said: “As the first biologic treatment in our therapeutic dermatology portfolio, Nemluvio shows our commitment to advancing dermatology by expanding into new areas of need.”
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By GlobalDataUnlike rival therapies, Nemluvio targets a receptor on interleukin-31, a neuroimmune cytokine that is involved in itch and drives inflammation in both AD and prurigo nodularis. Galderma licensed Nemluvio from Chugai Pharmaceutical in 2016.
The AD market is predicted to reach $16.7bn by 2030 across the seven major markets, which include the US, France, Germany, Italy, Spain, the UK, and Japan.
AD affects around ten to 40 million people in the European Union (EU), with up to 66% of adults suffering from a moderate-to-severe form of the condition. Prurigo nodularis is rarer – fewer than 100 people per 100,000 live with it in most countries in the EU.
With approval for its monoclonal antibody, though, Galderma enters a crowded AD space in Europe. Nemluvio will have to compete with Sanofi and Regneron’s mega-blockbuster drug Dupixent (dupilumab), which was approved in Europe for AD in 2017. Sales for the drug grew again by 16% in Q4 2024, generating more than $13.63bn in global sales for the two companies for the whole year. Dupixent is forecast to reach nearly $24bn in sales by 2030, according to GlobalData’s Pharma Intelligence Center.
There’s also Eli Lilly’s Ebglyss (lebrikizumab) to contend with, an interleukin-13 targeting therapy that won approval for AD in late 2023. A GlobalData analyst has already stated Lilly’s asset will capture market share from Dupixent in the US.
Despite the rivalries lying in wait, Galderma is hopeful for its injection. The pharma company expects Nemluvio to approach blockbuster status by the end of 2027, with peak sales topping $2bn.
