Leo Pharma Announces US Availability of Tralokinumab Single-Dose Autoinjector

Jonathan Silverberg, MD, PhD, MPH
Credit: George Washington University

Leo Pharma has announced US availability of the single-dose autoinjector version of tralokinumab (Adbry) for adult patients with moderate-to-severe atopic dermatitis.

Announced on September 17, 2024, Leo Pharma’s availability announcement comes just more than 3 months after the single-dose autoinjector of tralokinumab received approval from the US Food and Drug Administration (FDA) for the treatment of moderate-to-severe atopic dermatitis.^1,2

"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 on a daily basis, 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," said Jonathan Silverberg, MD, PhD, Professor of Dermatology, of George Washington University.¹ "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."

Billed as the first FDA-approved biologic that specifically binds to and inhibits the IL-13 cytokine, the initial approval for tralokinumab came in December 2021 in the form of an approval for treatment of moderate-to-severe atopic dermatitis. In December 2023, the FDA expanded this approval to included pediatric patients aged 12 to 17 years. In June 2024, the single-dose auto injector received approval from the FDA.^2,3

According to Leo Pharma, the single-dose 300 mg/2 mL autoinjector provides an additional option to the 150 mg/1mL pre-filled syringe, which will allow patients access to an additional option that requires half the number of injections compared to the 150 mg/1 mL pre-filled syringe. In their release, Leo Pharma pointed out the pre-filled syringe option will still be available.¹

The initial approval of tralokinumab was based clinical trial data from more than 1500 people included within the ECZTRA 1, 2 and ECZTRA 3 pivotal Phase 3 trials, which all met their primary endpoints. Specifically, results of the trials suggested use of tralokinumab was associated with a significant effect on Investigator's 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) relative to placebo therapy.^2,3

"We are proud to expand the administration options for Adbry and the choices available for those adults who are living with [atopic dermatitis]," said Brian Hilberdink, executive vice president and president of Region North America at LEO Pharma.¹ "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.”

References:

1. Leo Pharma. Adbry® (tralokinumab-ldrm) autoinjector now available for the treatment of adults with moderate-to-severe atopic dermatitis (AD) in the U.S. Business Wire. September 17, 2024. Accessed September 17, 2024. https://www.businesswire.com/news/home/20240917408534/en/.
2. Smith T. FDA approval of single-dose tralokinumab autoinjector for adults with atopic dermatitis. HCP Live. June 13, 2024. Accessed September 17, 2024. https://www.hcplive.com/view/fda-approval-of-single-dose-tralokinumab-autoinjector-for-adults-with-atopic-dermatitis.
3. National Eczema Association. Leo Pharma Inc.. announces U.S. FDA approval of Adbry® (tralokinumab-LDRM) for the treatment of moderate-to-severe atopic dermatitis in pediatric patients aged 12-17 years. National Eczema Association. December 15, 2023. Accessed September 17, 2024. https://nationaleczema.org/blog/leo-121523/.