• The FDA has approved Neurocrine's Crenessity as an adjunct therapy for classic congenital adrenal hyperplasia, offering patients a way to reduce steroid treatment burden. • Checkpoint Therapeutics received FDA approval for Unloxcyt to treat advanced cutaneous squamous cell carcinoma, targeting a $1 billion market opportunity. • Galderma's Nemluvio gains FDA approval for moderate-to-severe atopic dermatitis in patients 12 and older, with projected peak annual sales exceeding $2 billion.

• The FDA has approved Nemluvio (nemolizumab) for moderate-to-severe atopic dermatitis in patients 12 years and older when topical treatments are inadequate. • Nemolizumab is the first monoclonal antibody targeting IL-31 receptor alpha, offering a novel approach to reduce itch and inflammation associated with atopic dermatitis. • Clinical trials showed significant improvements in skin clearance, itch relief, and sleep disturbance with nemolizumab in combination with topical treatments. • Galderma anticipates peak sales of nemolizumab to exceed $2 billion, with potential blockbuster status by the end of 2027.

• Newly published results in JAMA Dermatology demonstrate nemolizumab monotherapy significantly improved itch intensity and skin lesions in patients with moderate-to-severe prurigo nodularis compared to placebo. • The OLYMPIA 1 trial showed rapid response as early as Week 4, with over six times more nemolizumab-treated patients achieving itch response and twenty times more reaching an itch-free or nearly itch-free state compared to placebo. • Based on the OLYMPIA clinical trial program, nemolizumab (Nemluvio®) received FDA approval for adult prurigo nodularis in August 2024, with additional regulatory reviews ongoing worldwide.

Prurigo nodularis and atopic dermatitis share underlying mechanisms, particularly related to chronic itch, with similar cytokines conserved between the diseases.

A Phase 3b study presented at Fall Clinical 2024 indicates potential efficacy in clearing moderate psoriasis in sensitive areas for patients who have not responded to topical treatments.