In June of this year, Leo Pharma's atopic dermatitis drug Adbry was approved by the U.K. and the EU. Now, the FDA has followed suit. (FDA)

Hoping to cut into the dominance of Dupixent, Leo Pharma of Denmark has gained FDA approval for Adbry (tralokinumab) as a treatment for moderate to severe atopic dermatitis.

The injected antibody drug is for adults 18 and older who don’t get adequate relief from topical prescription therapies. It can be used in combination with topical cortiocosteroids.    

Leo obtained tralokinumab from AstraZeneca for $115 million in 2016. The drug, which inhibits the IL-13 cytokine, was originally developed to treat asthma. Sanofi and Regeneron’s Dupixent, an injected drug which simultaneously inhibits the IL-13 and IL-4 cytokines, was approved for eczema (atopic dermatitis) in 2017 and asthma in 2018.

“Adbry is the first and only FDA approved biologic that specifically binds to the (IL-13) and is arguably the most targeted treatment available now for atopic dermatitis,” Jonathan Silverberg, M.D., Ph.D., of George Washington University and clinical trial investigator for tralokinumab, told Dermatology Times.

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In June of this year, the drug was approved in the U.K. and the EU. It is marketed outside of the U.S. as Adtralza. Leo said it will launch Adbry in the U.S. in February.

Atopic dermatitis is an inflammatory skin disease causing intense itch and lesions. The inflammation is caused by skin barrier dysfunction and immune dysregulation.

Endorsement of Adbry is based on results of three phase 3 trials that included nearly 2,000 patients with moderate to severe atopic dermatitis. The studies showed that Adbry alone or with topical cortiocosteroids as needed met the primary endpoints at Week 16, which were a measurement of skin clearance, improvement and severity of eczema.

While Adbry met the primary and secondary endpoints when measured against placebo, cross-trial data comparisons favor juggernaut Dupixent, which racked up sales of more than $4 billion in 2020 and $4.4 billion through three quarters of this year.  

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Pfizer has also filed for FDA approval of its atopic dermatitis candidate, Cibinqo, which was approved in the U.K. in September but remains in limbo in the U.S. because of safety concerns with JAK inhibitors. A phase 3 trial showed that the daily oral treatment topped Dupixent in helping patients achieve skin clearance.

Another promising candidate in phase 3 testing is Eli Lilly's lebrikizumab, which has also outperformed Adbry in cross-trial comparisons. 

The win for Leo comes after the departure of two-year CEO Catherine Mazzacco four weeks ago. The privately owned 113-year-old company is preparing for an initial public offering targeted for 2026-27. Chief Financial Officer Anders Kronborg has stepped in to fill the CEO role on an interim basis.