Nektar Therapeutics’ Rezpegaldesleukin Receives FDA Fast Track Designation for Atopic Dermatitis Treatment

Nektar Therapeutics has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its investigational biologic, rezpegaldesleukin, in the treatment of moderate-to-severe atopic dermatitis in adult and pediatric patients aged 12 years and older. This designation recognizes the urgent need for new treatment options in patients whose condition is not adequately managed by topical therapies. Rezpegaldesleukin works by targeting the interleukin-2 receptor complex to stimulate regulatory T cells (Tregs), which are involved in modulating the immune system and preventing inflammation.

In early clinical studies, rezpegaldesleukin has shown promising results, improving disease outcomes rapidly during the 12-week induction phase and maintaining those effects for at least 36 weeks post-treatment. Positive proof-of-concept data was presented at the 2023 EADV Congress, confirming the potential of this therapy to fill a significant unmet need in atopic dermatitis treatment.

Jonathan Zalevsky, Ph.D., Senior VP and Chief Research & Development Officer at Nektar, expressed enthusiasm over the FDA’s Fast Track designation. This designation not only allows Nektar to engage more closely with the FDA but also opens the door for faster regulatory review, which could accelerate the availability of this therapy to patients in need.

The ongoing REZOLVE-AD Phase 2b study is evaluating the efficacy of various dose regimens of rezpegaldesleukin in patients with moderate-to-severe atopic dermatitis who have not previously been treated with biologic or JAK inhibitor therapies. The trial is being conducted across more than 100 sites globally, with the goal of achieving significant improvements in disease severity and quality of life for patients.

Rezpegaldesleukin’s development is part of Nektar’s broader pipeline targeting autoimmune and inflammatory diseases. The therapy is also being evaluated in other clinical trials, including a study for alopecia areata. With this promising Fast Track designation, Nektar is well-positioned to make strides in the treatment of autoimmune conditions, offering hope for millions of patients suffering from atopic dermatitis and beyond.

Atopic dermatitis, affecting over 30 million people in the United States alone, remains a condition with limited treatment options, making the approval of rezpegaldesleukin a significant step forward in addressing this widespread inflammatory disease.

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