The therapeutic is the first biologic launched by LEO Pharma in the United States and is expected to be available in pharmacies by February 2022.
The FDA has approved tralokinumab-ldrm (Adbry, LEO Pharma) for the treatment of moderate-to-severe atopic dermatitis (AD) for adults whose disease is not well controlled with topical prescription therapies or when those therapies are not advisable.
Tralokinumab-ldrm can be used with or without topical corticosteroids.
Tralokinumab-ldrm is an injection and is the first and only FDA-approved biologic that binds to and inhibits the IL-13 cytokine, a key driver of AD signs and symptoms.
“Today’s FDA approval of Adbry is a major milestone for LEO Pharma and for the millions of people living with moderate-to-severe atopic dermatitis who struggle to find effective control for this chronic and debilitating disease,” Anders Kronborg, chief financial officer and acting CEO of LEO Pharma A/S, said in a statement. “As our first biologic in the U.S., Adbry signifies important progress in our mission of advancing the standard of care in medical dermatology.”.
The approval is based on efficacy and safety results from the ECZTRA 1, 2 and ECZTRA 3 phase 3 trials. The studies included nearly 2000 individuals with moderate-to-severe AD.
Safety data was evaluated from a pool of 5 double-blind, placebo-controlled, randomized trials.
In all 3 trials, the tralokinumab-ldrm 300 mg injection every other week, alone or with topical corticosteroids as needed, met the primary endpoint at week 16, measured by an Investigator Global Assessment score of clear or almost clear skin, and/or at least 75% improvement in the Eczema Area and Severity score.
The secondary endpoint of reduction of weekly average Worst Daily Pruritus NRS of ≥ 4 points on the 11-point itch NRS was also met.
The safety was also well established with an overall frequency of adverse events (AEs)compared with the placebo.
“Atopic dermatitis can be severe and unpredictable, which makes it not only challenging for patients to achieve long-term disease control but also for clinicians to treat, since there are limited treatment options for this burdensome chronic skin disease,” Jonathan Silverberg, MD, PhD, MPH, associate professor of dermatology at George Washington University School of Medicine and Health Sciences, and tralokinumab clinical trial investigator, said in the statement. “Adbry will be an important addition to our therapeutic armamentarium as a treatment designed to specifically target and neutralize the IL-13 cytokine, thereby, helping patients manage their atopic dermatitis.”
Tralokinumab-ldrm is expected to be available by February 2022 in a 150-mg/mL prefilled syringe for subcutaneous injection with an initial dose of 600 mg followed by 300 mg every other week. A dosage of 300 mg every 4 weeks may be considered for individuals below 100 kg who achieve clear or almost clear skin after 16 weeks of treatment.
Serious AEs include breathing problems, eye problems, hives, hypotension, itching, skin rash, and swelling of the face, mouth, and tongue.
Other common adverse events include eosinophilia, eye and eyelid inflammation, and injection site reaction.
LEO Pharma announces FDA approval of Adbry™ (tralokinumab-ldrm) as the first and only treatment specifically targeting IL-13 for adults with moderate-to-severe atopic dermatitis. Virgo Health. News release. December 28, 2021. Accessed January 3, 2022. Email.