FDA approves single dose autoinjector for atopic dermatitis

The US food and Drug Administration has approved a new 300 mg single-dose autoinjector for tralokinumab-ldrm (Adbry) for adults with moderate-to-severe atopic dermatitis (AD).

Adbry, a high-affinity fully human monoclonal antibody, is currently indicated in the U.S. for the treatment of moderate-to-severe atopic dermatitis in patients aged 12 years and older.

The new autoinjector will provide another option for adult patients in addition to the pre-filled syringe administration that is currently available. Prior to the introduction of the autoinjector, Adbry was only available in a 1 mL pre-filled syringe. With the new 2 mL autoinjector, adult patients now have a more convenient option with half the number of required injections compared to the 1 mL 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,” said Brian Hilberdink, EVP and President, Region North America, LEO Pharma. “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.”

For patients who prefer the pre-filled syringe, this option will continue to be available in the U.S.

“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,” commented Shannon Schneider, Senior Medical Affairs Director, LEO Pharma. “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.”

In the U.S., Adbry is available in a single-use pre-filled syringe (150 mg/1 mL) as well as a single-use autoinjector (300 mg/2 mL). Adbry 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 patients.

Adbry (tralokinumab-ldrm) is marketed outside of the U.S. under the tradename Adtralza® (tralokinumab) and is approved for the treatment of adults and pediatric patients (12 years and above) with moderate-to-severe AD in the U.S., Canada, the European Union, the United Arab Emirates, Great Britain, and South Korea. Adtralza is approved for use in adults with moderate-to-severe AD in Saudi Arabia, Switzerland, and Japan.

About atopic dermatitis

Atopic dermatitis is a chronic, inflammatory skin disease characterized by intense itch and eczematous lesions. Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation. Type 2 cytokines, including IL-13, play an important role in the key aspects of atopic dermatitis pathophysiology.

About Adbry® (tralokinumab-ldrm)

Adbry® (tralokinumab-ldrm), which is marketed outside of the U.S. under the tradename Adtralza® (tralokinumab), is a high-affinity fully human monoclonal antibody developed to bind to and inhibit the interleukin (IL)-13 cytokine, which plays a role in the immune and inflammatory processes underlying atopic dermatitis signs and symptoms. Adbry® specifically binds to the IL-13 cytokine, thereby inhibiting interaction with the IL-13 receptor α1 and α2 subunits (IL-13Rα1 and IL-13Rα2).