FDA Approves Adbry Autoinjector for the Treatment of Adults with Moderate-to-Severe Atopic Dermatitis (AD)


The FDA has approved LEO Pharma's Adbry (tralokinumab-ldrm) 300 mg single-dose autoinjector for the treatment of moderate-to-severe atopic dermatitis in patients aged 12 years and older.1

The new autoinjector  (300 mg/2 mL) 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 pre-filled syringe (150 mg/1 mL). With the new 2 mL autoinjector, half the number of required injections are required compared to the 1 mL pre-filled syringe, according to Leo Pharma.

“We are constantly looking for new ways to advance the standard of care and improve the patient experience for our treatment options. Through this latest approval, a new mode of administration has been made available to provide a more convenient option to support self-administration," Brian Hilberdink, EVP and President, Region North America, LEO Pharma, said in a company news release. "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 US.

Adbry received approval from the 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.

Adbry(tralokinumab-ldrm) is marketed outside of the US 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 US, 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.

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