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The FDA approved the first atopic dermatitis (AD) therapy that targets interleukin (IL)-13.

Subcutaneous injection of tralokinumab (Adbry) received approval for adults with moderate-to-severe AD who are candidates for systemic therapy, LEO Pharma announced. The drug is approved in Europe and Canada for the same indication.

"Atopic dermatitis can be severe and unpredictable, which makes it not only challenging for patients to achieve long-term disease control, but also for clinicians to treat, since there are limited treatment options for this burdensome chronic skin disease," said Jonathan Silverberg, MD, PhD, of George Washington University in Washington, D.C., in a from the drugmaker. "Adbry will be an important addition to our therapeutic armamentarium as a treatment designed to specifically target and neutralize the IL-13 cytokine, thereby helping patients manage their atopic dermatitis."

Support for the approval came from three randomized phase III trials (ECZTRA 1, 2, and 3) that included almost 2,000 adults with moderate-to-severe AD. Safety data came from the same three trials plus two additional randomized trials.

Investigators in the three ECZTRA trials compared tralokinumab (with or without topical corticosteroids) and placebo for the primary endpoint of Investigator Global Assessment (IGA) score of 0 or 1 (clear or almost clear) or at least 75% improvement in the Eczema Area and Severity Index score (EASI75) after 16 weeks of treatment. The key secondary endpoint was at least a 4-point improvement in the weekly average of worst daily pruritis, as assessed by the 11-point Numerical Rating Scale (NRS) for itch.

In the trials (which evaluated tralokinumab monotherapy), more than twice as many patients met the IGA endpoint with the IL-13 inhibitor as compared with placebo (16% and 21% vs 7% and 9%, respectively). Additionally, 25% and 33% of tralokinumab-treated patients met the EASI75 endpoint as compared with 13% and 10% of placebo-treated patients. Also at week 16, 20% and 25% of patients allocated to tralokinumab had at least a 4-point improvement in the NRS versus 10% and 9% of patients randomized to placebo.

At 52 weeks, 50% to 60% of patients who met IGA or EASI75 response criteria at 16 weeks maintained the responses.

was a placebo-controlled trial that evaluated tralokinumab in combination with topical corticosteroids. The week-16 results were similar to those observed in the ECZTRA 1 and 2 trials, and improvement was maintained in about 90% of patients at week 32.

The most common side effects associated with tralokinumab included eye and eyelid inflammation, injection-site reactions, and increased eosinophil count.

According to LEO Pharma, tralokinumab will be available in the U.S. by February.

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