FDA Approves Tralokinumab Autoinjector for Adults with Moderate-to-Severe Atopic Dermatitis

The US Food and Drug Administration (FDA) has approved a new Adbry (tralokinumab-ldrm) 300 mg single-dose autoinjector, offering a new administration option for adult patients with moderate-to-severe atopic dermatitis (AD). LEO Pharma Inc. announced that this device will be available in the coming months, enhancing patient convenience with easier self-administration.

This new autoinjector aims to streamline the treatment process by reducing the number of required injections. Previously, Adbry was only available in a 1 mL pre-filled syringe, necessitating multiple injections. The 2 mL autoinjector simplifies administration by halving the number of injections needed.

“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. “This approval provides a new mode of administration that offers greater convenience for self-administration. Our team will now work to ensure patients across the United States can access this device in the coming months.”

The approval of the autoinjector increases options for the estimated 6.6 million adults in the United States living with moderate-to-severe AD. The new autoinjector complements the existing pre-filled syringe, providing patients with more choices in managing their condition.

Shannon Schneider, Senior Medical Affairs Director at LEO Pharma, emphasized the importance of offering multiple administration options: “We understand that no patient is the same, and this extended approval represents a positive step forward in providing those living with AD more choices. Alongside the pre-filled syringe, the autoinjector offers U.S. adult patients unprecedented flexibility in how they administer their treatment.”

Adbry is now available as a single-use pre-filled syringe (150 mg/1 mL) and a single-use autoinjector (300 mg/2 mL). Initially approved by the FDA in December 2021 for the treatment of moderate-to-severe AD in adults, Adbry’s indication was expanded in December 2023 to include pediatric patients aged 12 years and older. The recent approval of the autoinjector in June 2024 is specifically for adult patients.

Outside the United States, Adbry is marketed under the tradename Adtralza (tralokinumab) and is approved for the treatment of moderate-to-severe AD in adults and pediatric patients (12 years and above) in countries including Canada, the European Union, the United Arab Emirates, Great Britain, and South Korea. Adtralza is also approved for adult use in Saudi Arabia, Switzerland, and Japan.

The introduction of the autoinjector marks a significant milestone in the management of atopic dermatitis, providing adult patients with a more convenient and efficient treatment option, ultimately enhancing their quality of life.

Reference:

FDA approves Adbry (tralokinumab-ldrm) autoinjector for the treatment of adults with moderate-to-severe atopic dermatitis (AD). News release. Business Wire. June 13, 2024. Accessed June 15, 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