Nektar's Jonathan Zalevsky, PhD, Dives Into Rezpegaldesleukin Fast Track Designation for Atopic Dermatitis

Nektar Therapeutics recently announced that the FDA granted Fast Track designation to its investigational drug rezpegaldesleukin (Rezpeg) for the treatment of atopic dermatitis (AD).¹

Read more from Dermatology Times.

In a recent interview with Dermatology Times, Jonathan Zalevsky, PhD, chief of research and development at Nektar Therapeutics, discussed the significance of this designation, the unmet need in AD treatment, and what sets rezpegaldesleukin apart from existing therapies.

Understanding Fast Track Designation

The FDA’s Fast Track program is designed to expedite the development of drugs that address serious conditions with unmet medical needs. According to Zalevsky, “Fast Track focuses on pre-clinical information, and it recognizes and really defines the unmet need in the disease.”

He explained that while most currently available biologics for AD target the IL-13 pathway, rezpegaldesleukin operates differently. “The FDA realizes that the unique mechanism of action of REZPEG... really could push the envelop," he noted.

Addressing an Ongoing Unmet Need in AD Treatment

Despite the approval of 3 systemic biologics—dupilumab (Dupixent), tralokinumab (Adbry), and lebrikizumab (Ebglyss)—Zalevsky emphasized that many patients with AD still struggle to achieve optimal disease control.

“There’s definitely a lot of benefit that a lot of people see, but there is still an unmet need,” he said. “The unmet need is about the same as it was when Dupixent entered.”

What Sets Rezpeg Apart?

Unlike current biologics, which primarily target IL-13 and IL-4 pathways, rezpegaldesleukin modulates the IL-2 pathway, offering a unique immunological approach to AD treatment, according to Zalevsky. He noted that the data collected and outcomes observed to date are "somewhat unprecedented."

Fast Track Benefits and Next Steps

The Fast Track designation grants Nektar Therapeutics greater access to FDA resources, including more frequent meetings and faster regulatory review times.

“It means we get more access to the FDA. We can request more meetings and have access to them more. We can also request different types of consultation,” Zalevsky explained. These benefits may help accelerate the clinical development of rezpegaldesleukin and potentially bring a new treatment option to patients with AD even sooner.

Reference

1. Nektar Therapeutics receives fast track designation for rezpegaldesleukin for the treatment of moderate-to-severe atopic dermatitis. News release. PRNewswire. February 10, 2025. Accessed February 14, 2025. https://www.prnewswire.com/news-releases/nektar-therapeutics-receives-fast-track-designation-for-rezpegaldesleukin-for-the-treatment-of-moderate-to-severe-atopic-dermatitis-302371995.html