FDA approval marks the fifth global regulatory approval for tralokinumab in 2021

FDA has approved Adbry™ (tralokinumab-ldrm) from LEO Pharma Inc. for the treatment of moderate-to-severe atopic dermatitis in adults 18 years or older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Adbry is the first and only FDA approved biologic that specifically binds to and inhibits the IL-13 cytokine, a key driver of atopic dermatitis signs and symptoms.

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. 

In all three pivotal trials, Adbry 300mg 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. Adbry can be used with or without topical corticosteroids.

Safety data were 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. In clinical trials, the safety of Adbry was well established with an overall frequency of adverse events comparable with placebo. 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.

“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,” says 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.” 

“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,” says Anders Kronborg, Chief Financial Officer and Acting Chief Executive Officer of LEO Pharma A/S. “As our first biologic in the US, Adbry signifies important progress in our mission of advancing the standard of care in medical dermatology.” 

Adbry will be available in a 150mg/mL prefilled syringe for subcutaneous injection with an initial dose of 600mg followed by 300mg every other week. A dosage of 300mg every four weeks may be considered for patients below 100kg who achieve clear or almost clear skin after 16 weeks of treatment.

LEO Pharma will introduce the Adbry Advocate Program to support US patients at diagnosis and throughout treatment with Adbry. Details about the Adbry Advocate Program will be available at 1-844-MYADBRY (1-844-692-3279) or www.ADBRY.com. 

The FDA approval marks the fifth global regulatory approval for tralokinumab in 2021. Tralokinumab is marketed outside of the US under the tradename Adtralza® and is currently approved in the European Union, Great Britain, Canada, and the United Arab Emirates.