FDA Approves New Tralokinumab-ldrm Autoinjector

The US Food and Drug Administration (FDA) announced the approval of a new tralokinumab-ldrm 300-mg single-dose autoinjector for adult patients.

Adbry® (LEO Pharma Inc.), a high-affinity fully human monoclonal antibody, is currently indicated in the US for the treatment of moderate-to-severe atopic dermatitis in patients 12 and older.

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 for 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.”

The pre-filled syringe will continue to be available in the US 

“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,” said Shannon Schneider, Senior Medical Affairs Director for LEO Pharma. “Alongside the previously approved pre-filled syringe, the autoinjector will give adult patients in the US more options than ever before in how they administer their treatment.”