FDA Approves Expanded Use of VTAMA and Nemluvio for Atopic Dermatitis Treatment

FDA Approvals:

The FDA has approved Organon's VTAMA (tapinarof) cream 1% for the treatment of atopic dermatitis in adults and children as young as 2 years old3 4.
Galderma's Nemluvio (nemolizumab) has been approved for the treatment of moderate-to-severe atopic dermatitis in patients aged 12 years and older, in combination with topical corticosteroids and/or calcineurin inhibitors1 2.

Clinical Trials:

VTAMA's approval was based on the ADORING trials, which showed significant improvements in skin clearance and itch relief compared to placebo3 4.
Nemluvio's approval was supported by the Phase III ARCADIA clinical trial program, demonstrating significant improvements in skin clearance when used in combination with topical corticosteroids and/or calcineurin inhibitors1 2.

Market Impact:

These approvals address significant unmet needs in atopic dermatitis treatment, offering new therapeutic options for patients with moderate-to-severe forms of the disease.
Galderma anticipates Nemluvio to achieve blockbuster net sales run-rate by the end of 2027, with peak sales expected to exceed $2 billion2.

Regulatory Progress:

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of Nemluvio for the treatment of atopic dermatitis and prurigo nodularis in the European Union5.
Further submissions to other regulatory authorities are planned for 20252 5.