Sanofi and Regeneron have announced that the US Food and Drug Administration (FDA) has approved a label update for Dupixent (dupilumab) in atopic dermatitis.
The US label for the IL-4 and IL-13 inhibitor now includes efficacy and safety data for patients aged 12 years and older with atopic dermatitis with uncontrolled moderate-to-severe hand and/or foot involvement.
Typically referred to as eczema, atopic dermatitis is a common inflammatory skin disorder characterised by dry, itchy and cracked skin, usually affecting the folds of the arms, back of the knees, hands, feet, face and neck.
“Living with atopic dermatitis on your most essential body areas like the hands and feet can make daily activities including walking and writing incredibly burdensome even in the case where disease symptoms are mild elsewhere,” explained Naimish Patel, head of global development, immunology and inflammation at Sanofi.
The phase 3 LIBERTY-AD-HAFT trial evaluated Dupixent in 133 adult and adolescents with moderate-to-severe atopic hand and/or foot dermatitis who had an inadequate response or intolerance to topical corticosteroids.
LIBERTY-AD-HAFT, which is the first trial to have evaluated a biologic specifically for this patient population, met its primary endpoint, with 40% of Dupixent-treated patients achieving clear or almost clear skin on their hands and feet at week 16 compared to 17% receiving placebo.
The key secondary endpoint of the study was also met, with 52% of Dupixent-treated patients reporting a clinically meaningful reduction in itch on their hands and feet at week 16 compared to 14% in the placebo cohort.
George Yancopoulos, board co-chair, president and chief scientific officer at Regeneron, said: “Dupixent has been used to treat hundreds of thousands of patients with moderate-to-severe atopic dermatitis around the world since its initial US approval in 2017, and we are pleased that Dupixent is now the first biologic with data in the label supporting its use in this particularly challenging subset of the disease.”
Dupixent has already received regulatory approvals for use in certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic oesophagitis and prurigo nodularis.
As well as the currently approved indications, the partners are studying Dupixent across a broad range of diseases driven by type 2 inflammation or other allergic processes, including certain patients with urticaria, chronic pruritus and chronic obstructive pulmonary disease.