FDA approves tralokinumab for moderate-to-severe atopic dermatitis

"Today's FDA approval of Adbry is a major milestone for LEO Pharma and for the millions of people living with moderate-to-severe atopic dermatitis who struggle to find effective control for this chronic and debilitating disease," said Anders Kronborg, Chief Financial Officer and Acting Chief Executive Officer of LEO Pharma A/S. "As our first biologic in the U.S., Adbry signifies important progress in our mission of advancing the standard of care in medical dermatology."

The approval of Adbry is based on safety and efficacy results from the ECZTRA 1, 2 and ECZTRA 3 pivotal Phase 3 trials, which included nearly 2,000 adult patients with moderate-to-severe atopic dermatitis.1 Safety data was evaluated from a pool of five randomized, double-blind, placebo-controlled trials, including ECZTRA 1, 2 and ECZTRA 3, a dose-finding trial, and a vaccine response trial.1

In all three pivotal trials, Adbry 300 mg every other week alone or with topical corticosteroids (TCS) as needed met the primary endpoints at Week 16 as measured by an Investigator Global Assessment score of clear or almost clear skin (IGA 0/1) and/or at least a 75% improvement in the Eczema Area and Severity Index score (EASI-75), and the secondary endpoint of reduction of weekly average Worst Daily Pruritus NRS of ≥ 4 points on the 11-point itch NRS.1

In clinical trials, the safety of Adbry was well established with an overall frequency of adverse events comparable with placebo.1 The most common adverse events (incidence ≥1% and greater than placebo) were upper respiratory tract infections (mainly reported as common cold), conjunctivitis, injection site reactions, and eosinophilia.1

"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, MPH, Associate Professor of Dermatology at George Washington University School of Medicine and Health Sciences, and tralokinumab clinical trial investigator. "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."

Adbry will be available in a 150 mg/mL prefilled syringe for subcutaneous injection with an initial dose of 600 mg followed by 300 mg every other week. Adbry can be used with or without TCS. 1 A dosage of 300 mg every four weeks may be considered for patients below 100 kg who achieve clear or almost clear skin after 16 weeks of treatment.

"For people living with atopic dermatitis, the experience goes beyond the skin, often impacting important psychosocial aspects of their life," said Julie Block, President and CEO of the National Eczema Association. "It's exciting to see a new targeted therapeutic option for adult patients living with moderate-to-severe atopic dermatitis. Therapeutic advances like this provide much needed hope for those who may have spent years struggling to find an effective therapy to alleviate the burden of this disease."