LEO Pharma's Tralokinumab-ldrm Autoinjector Now Available in US for Adults With Moderate to Severe Atopic Dermatitis

LEO Pharma announced today that its 300 mg/2 mL single-dose autoinjector of tralokinumab-ldrm (Adbry) is now available for US adults with moderate to severe atopic dermatitis (AD).¹

The US Food and Drug Administration (FDA) approved the autoinjector device in June.² It allows adults with AD to reduce the number of self injections administered by half, as until now, the previous dosage of the Adbry pre-filled syringe measured 150 mg/1 mL.

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Tralokinumab was approved by the FDA for patients aged 12 and older in an expanded indication in December 2023³ 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.

"I understand from discussions with my patients that living with AD already brings a wide range of difficulties and debilitating factors that need to be managed on a daily basis, so it is integral that any treatment solution is more convenient to manage for those living with the condition, and does not add even more of a burden," said Jonathan Silverberg, MD, PhD, in a news release.¹ Silverberg is a professor of dermatology at George Washington University.

"This new administration option reduces the number of injections required overall and provides adults living with AD with an additional option in how they manage their condition," Silverberg said.

Patients who prefer using the pre-filled syringe for their treatments will still have that option available. It will remain available for adult and pediatric patients ages 12 to 17.

Shannon Schneider, senior medical affairs director at LEO Pharma, previously 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 a June news release following approval from the FDA.² "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."

Adults start with a 600 mg dose (either 4 syringes or 2 autoinjector injections) and then switch to a 300 mg maintenance dose every 2 weeks (either 2 syringes or 1 autoinjector injection). Those who achieve significant skin improvement and weigh less than 220 pounds can opt for a single monthly 300 mg dose after 16 weeks.

"We are proud to expand the administration options for Adbry and the choices available for those adults who are living with AD," said Brian Hilberdink, EVP and president, North America region, of LEO Pharma.¹ "Today’s news supports our goal to help improve the standard of care for those living with skin diseases and highlights our commitment to innovation. We will continue to work tirelessly to improve the treatment options available for various skin conditions in the US."

References

1. Adbry (tralokinumab-ldrm) autoinjector now available for the treatment of adults with moderate-to-severe atopic dermatitis (AD) in the US. News release. Business Wire. September 17, 2024. Accessed September 17, 2024. https://www.businesswire.com/news/home/20240917408534/en/Adbry%C2%AE-tralokinumab-ldrm-Autoinjector-Now-Available-for-the-Treatment-of-Adults-with-Moderate-to-Severe-Atopic-Dermatitis-AD-in-the-U.S.?_gl=1*zquru1*_gcl_au*MTgwMDAxNTkwOS4xNzIzNzMzNTk1LjEwMzQ1MzE1NDIuMTcyNjU2OTcwMi4xNzI2NTY5NzAy*_ga*ODI3NzA5MTQ3LjE3MTU2OTEzMDA.*_ga_ZQWF70T3FK*MTcyNjU2OTM4MS4yMS4xLjE3MjY1Njk3OTIuMzUuMC4w
2. 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 September 17, 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
3. LEO Pharma Inc. announces US 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 September 17, 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