FDA Approves Tralokinumab Autoinjector for Adults With Moderate to Severe Atopic Dermatitis

Image Credit: © Calin - stock.adobe.com

The US Food and Drug Administration (FDA) has approved LEO Pharma's tralokinumab-ldrm (Adbry) single-use autoinjector for adults with moderate to severe atopic dermatitis (AD).¹

The 300 mg autoinjector device is expected to become available to patients in the coming months, providing an alternative method of administration for the biologic drug, which currently utilizes a pre-filled syringe.

As a 2 mL autoinjector, patients are now provided with the option to receive half as many injections, given that the previously-approved pre-filled injector contains 1 mL.

Tralokinumab was approved by the FDA for patients aged 12 and older in an expanded indication in December² and is currently approved for use in adolescents and adults with moderate to severe AD in the US, Canada, European Union, Great Britain, United Arab Emirates, and South Korea.

Under its non-US marketed trade name, Adtralza, it is approved exclusively for adults with moderate to severe AD in Japan, Saudi Arabia, and Switzerland.

“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, in today's news release.¹ “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.”

Patients who prefer using the pre-filled syringe for their treatments will still have that option available. Shannon Schneider, senior medical affairs director at LEO Pharma, emphasized the importance of providing multiple choices to cater to the unique needs of each patient.

“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,” Schneider said in the news release.¹ “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 a recent interview with Dermatology Times at the 2024 Revolutionizing Alopecia Areata, Vitiligo, and Eczema Conference in Chicago, Illinois, Raj Chovatiya, MD, PhD, associate professor at the Rosalind Franklin University Chicago Medical School, founder and director of the Center for Medical Dermatology and Immunology Research in Chicago, and Dermatology Times’ 2024 Fall Editor in Chief, addressed the capabilities of biologics such as tralokinumab in achieving early responses.

“In the case of biologics like dupilumab and tralokinumab, you definitely will see some early responses," Chovatiya said. "Things will get better as you go on further along, perhaps even longer in the case of tralokinumab based on some speed differences compared to dupilumab, but similar depth overall by the end for good responders."

Dermatology Times will continue to follow this news and update our audience as the autoinjector becomes available to patients.

References

1. 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 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
2. Leo Pharma Inc. announces U.S. FDA approval of Adbry (tralokinumab-LDRM) for the treatment of moderate-to-severe atopic dermatitis in pediatric patients aged 12-17 years. Business Wire. December 15, 2023. Accessed June 13, 2024. https://www.businesswire.com/news/home/20231215374551/en/LEO-Pharma-Inc.-Announces-U.S.-FDA-approval-of-Adbry%C2%AE-tralokinumab-ldrm-for-the-Treatment-of-Moderate-to-severe-Atopic-Dermatitis-in-Pediatric-Patients-Aged-12-17-Years