The FDA has approved tralokinumab for treating moderate to severe atopic dermatitis in adults, according to a press release from the manufacturer. The biologic is the first and only therapy targeting the IL-13 cytokine to be approved by the FDA. IL-13 is a major driver of atopic dermatitis 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 a suitable treatment option for this chronic and debilitating disease,” Anders Kronborg, CFO and acting CEO of LEO Pharma A/S, said in a press release. “As our first biologic in the US, Adbry signifies important progress in our mission of advancing the standard of care in medical dermatology.”
The FDA based its approval in late December on the phase 3 ECZTRA 1, 2 and 3 trials The ECZTRA 1 and 2 trials were yearlong randomized, placebo-controlled, double blind trials conducted with nearly 1,600 adult patients. These studies examined the safety and efficacy of 300 mg of tralokinumab as a monotherapy every other week. The ECZTRA 3 trial (n = 380) lasted 32 weeks and was also a randomized, placebo-controlled double blind study evaluating the same dose of tralokinumab in combination with a topical corticosteroid.
“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 press release. “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 is administered by subcutaneous injection at an initial dose of 600 mg followed by 300 mg every other week, and can be used with or without topical corticosteroids. Patients who achieve clear or almost clear skin after 16 weeks of treatment and weigh less than 100 kg may have the option to reduce their dosage to 300 mg every four weeks.
“For people living with atopic dermatitis, the experience goes beyond the skin, often impacting important psychosocial aspects of their life,” Julie Block, president and CEO of the National Eczema Association, said in the announcement. “It’s exciting to see a new, targeted therapeutic option for adult patients living with moderate-to-severe atopic dermatitis. Therapeutic advances like this provide much needed hope for those who may have spent years struggling to find a suitable therapy to alleviate the burden of this disease.”
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