LEO LABORATORIES LIMITED

Leo Pharma received final approval for delgocitinib in Europe and is preparing to enter the US market with the JAK inhibitor.

LEO Pharma's NDA for delgocitinib cream, a potential treatment for moderate to severe Chronic Hand Eczema (CHE), has been accepted by the FDA. If approved, it would be the first treatment in the U.S. specifically for adults with CHE, a condition affecting 4.7% of the global population.

Leo Pharma introduces an additional option for US patients using eczema treatment Adbry, a key driver of North American sales.

FDA approves Eli Lilly's Ebglyss (lebrikizumab) for moderate-to-severe atopic dermatitis, offering once-monthly dosing. Ebglyss targets IL-13, providing clear skin in 38% of patients at 16 weeks, compared to 12% with placebo. Common side effects include eye inflammation, injection site reactions, and shingles.

Despite declining use of Sanofi/Regeneron’s Dupixent due to competition from LEO’s Adbry, Pfizer’s Cibinqo, and AbbVie’s Rinvoq, the overall population receiving advanced treatments for atopic dermatitis is rising, according to Spherix Global Insights. Dermatologists estimate that two-fifths of adult atopic dermatitis patients now receive advanced systemic treatments, highlighting the demand for effective AD treatments. The potential approvals of Galderma’s nemolizumab and Eli Lilly’s lebrikizumab could further shift physician preferences, with nemolizumab expected to gain more adoption than lebrikizumab.

Dupixent's dominance in atopic dermatitis treatment is diminishing with the rise of competitors like Adbry, Cibinqo, and Rinvoq. Dermatologists anticipate adopting nemolizumab and lebrikizumab, further challenging Dupixent's market share.