LEO Pharma’s Tralokinumab Single-Dose Autoinjector Available For Usage Just Over 3 Months From FDA Approval

Leo Pharma announces the availability of a single-dose auto-injector version of Tralokinumab in the U.S. Tralokinumab is available under the brand name “Adbry” across the U.S., principally used to treat patients with moderate to severe atopic dermatitis. The availability was announced by LEO Pharma just over three months after the FDA approved the drug across-the-counter

Initially, Tralokinumab was approved by the U.S. FDA in December 2021 for treating moderate-to-severe atopic dermatitis. Tralokinumab consists of a fundamental mechanism that specifically targets and inhibits the IL-13 cytokine, a protein that is associated with inflammation and immune response. Furthermore, the FDA approved the administration of pediatric patients aged 12 to 17 in December 2023. 

Jonathan Silverberg, MD, PhD, Professor of Dermatology at George Washington University, stated, "I understand from discussions with my patients that living with atopic dermatitis already brings a wide range of difficulties and debilitating factors that need to be managed daily, so it is integral that any treatment solution is more convenient to manage for those living with the condition, and does not add even more of a burden. This new administration option reduces the number of injections required overall and provides adults living with atopic dermatitis with an additional option in how they manage their condition."

The single-dose 300mg/2ml autoinjector provides all-over patients compliance as it reduces to directly half of the dose age duration, compared to 150mg/1ml of pre-filled syringe. Leo Pharma also emphasized that the pre-filled syringe will yet be an available option. 

The primary approval of Tralokinumab was supported by clinical trial data from over 1500 participants included in the pivotal Phase 3 ECZTRA 1, 2, and 3 trials, all of which attained their primary endpoints. The Investigator's Global Assessment score improved significantly due to Tralokinumab, leading to at least an improvement of 75% in the treatment Eczema and Severity Index score when compared to placebo therapy.

Brian Hilberdink, executive vice president and president of Region North America at LEO Pharma, said, "We are proud to expand the administration options for Adbry and the choices available for adults living with atopic dermatitis. Today’s news supports our goal to help improve the standard of care for those living with skin diseases and highlights our commitment to innovation. We will continue to work tirelessly to improve the treatment options available for various skin conditions in the US.”