FDA Approval of Single-Dose Tralokinumab Autoinjector for Adults with Atopic Dermatitis

An announcement was made by LEO Pharma, Inc. that the US Food and Drug Administration (FDA) approved a new 300 mg single-dose autoinjector for tralokinumab-ldrm (Adbry) for adults with moderate-to-severe atopic dermatitis (AD).¹

The drug itself is a fully human monoclonal antibody which has been approved for Americans treating moderate-to-severe eczema, specifically among those in the age range of 12 years and older. The option for an autoinjector version of tralokinumab therapy for adults provides an alternative option to the pre-filled syringe.

“We are constantly looking for new ways to advance the standard of care and improve the patient experience for our treatment options,” Brian Hilberdink, EVP and president of Region North America at LEO Pharma, said in a statement. “Through this latest approval, a new mode of administration has been made available to provide a more convenient option to support self-administration. Our team will now undertake the necessary steps to ensure patients living across the United States have access to this device in the coming months.”

Prior to the FDA’s approval, tralokinumab had been available only in a single mL, pre-filled syringe, making the chance for a 2 mL autoinjector option appealing to some atopic dermatitis patients seeking for fewer injections than the number required by the 1 mL pre-filled syringe, though the pre-filled syringe will continue to be available within the U.S.

Either a single, pre-filled, 150 mg/1 mL syringe or a single-use autoinjector (300 mg/2 mL) can be used for tralokinumab administration for those in the US. Tralokinumab had been approved by FDA officials in December 2021 for adults, though its indication was then expanded in December 2023 for individuals aged 12 years and older.

The use of an autoinjector for the drug’s administration was approved by the FDA in June 2024 for adult patients.

“We understand that no patient is the same, and through this extended approval we have taken a positive step forward to equip those living with AD with more choices,” Shannon Schneider, senior medical affairs director of LEO Pharma, said in a statement. “Alongside the previously approved pre-filled syringe, the autoinjector will give adult patients in the U.S more options than ever before in how they administer their treatment.”

Tralokinumab is marketed as Adtralza outside of the US, with the European Union, Canada, the United Arab Emirates, South Korea, and Great Britain having approved the drug for moderate-to-severe atopic dermatitis therapy among those aged 12 years and older. The treatment was also approved in Switzerland, Saudi Arabia, and Japan for treatment of adult patients with moderate-to-severe atopic dermatitis.

Recent data presented at the Revolutionizing Atopic Dermatitis (RAD) 2024 annual meeting by Jonathan Silverberg, MD, PhD, MPH, director of clinical research at George Washington University’s School of Medicine and Health Sciences, highlighted real-world findings on tralokinumab’s use among those with and without prior advanced systemic therapy, suggesting meaningful improvements in clinician-assessed and patient-reported outcomes.²

These findings and the FDA’s approval of the autoinjector option may lead to more widespread implementation of the drug in dermatologists’ armamentarium.

References

1. ^{FDA Approves Adbry® (tralokinumab-ldrm) Autoinjector for the Treatment of Adults with Moderate-to-Severe Atopic Dermatitis (AD). Leo Pharma, Inc. June 13, 2024. https://www.businesswire.com/news/home/20240613529061/en/FDA-Approves-Adbry%C2%AE-tralokinumab-ldrm-Autoinjector-for-the-Treatment-of-Adults-with-Moderate-to-Severe-Atopic-Dermatitis-AD. Date accessed: June 13, 2024.}
2. ^{Silverberg J, Balu S, Choi CJ, et al. Real-world effectiveness of persistent tralokinumab use on clinician and patient-reported outcomes in patients with atopic dermatitis in the CorEvitas atopic dermatitis registry. Abstract presented at Revolutionizing Atopic Dermatitis 2024. Chicago, Il. June 08-10, 2024.}