The U.S. Food and Drug Administration (FDA) has given its nod to tralokinumab-ldrm (Adbry, Leo Pharma) 300mg single-dose autoinjector for adults with moderate to severe atopic dermatitis (AD).
Tralokinumab-ldrmis is a high-affinity fully human monoclonal antibody developed to bind to and inhibit the interleukin (IL)-13 cytokine.
The new autoinjector is another option for adult patients in addition to the pre-filled syringe administration that is currently available. Prior to the introduction of the autoinjector, tralokinumab was only available in a 1mL pre-filled syringe. With the new 2mL autoinjector, adult patients now have a more convenient option with half the number of required injections compared to the 1mL pre-filled syringe.
In the U.S., Adbry is available in a single-use pre-filled syringe (150mg/1mL) as well as a single-use autoinjector (300mg/2mL). For patients who prefer the pre-filled syringe, this option will continue to be available in the U.S.
Tralokinumab-ldrm received approval from the U.S. FDA in December 2021 for the treatment of moderate-to-severe atopic dermatitis in adults. Subsequently, in December 2023, the indication was expanded to include pediatric patients 12 years and older. The autoinjector received approval in June 2024 for adult patient
