New Tralokinumab Approval with Jonathan Silverberg, MD, PhD, MPH


Dr. Silverberg speaks of the recent FDA approval of the biologic for patients with moderate-to-severe atopic dermatitis.

Last week, pharmaceutical company LEO Pharma announced that the Food and Drug Administration (FDA) had approved the biologic tralokinumab (Adbry) for the treatment of moderate-to-severe atopic dermatitis.

The biologic will soon be available in a 150 mg/mL pre-filled syringe for subcutaneous injection with an initial dose of 600 mg followed by 300 mg every other week, and the approval was made based on the strength of 3 phase 3 trials that included nearly 2000 patients with the skin disease.

To date, it is only biologic approved by the FDA that binds to and inhibits the interleukin (IL)-13 cytokine, noted as a key driver of signs and symptoms of atopic dermatitis.

In an interview with HCPLive, Jonathan I. Silverberg, MD, PhD, MPH, Department of Dermatology, The George Washington School of Medicine and Health Sciences, spoke of the implication of tralokinumab in the inhibition of the IL-13 cytokine, as well as what the biologic means for the future of atopic dermatitis management.

“Selective inhibition of IL-13 by Adbry was shown to be both highly effective and have an outstanding safety profile in the clinical trial,” Silverberg said. “We’re excited because, Adbry is an important addition to our therapeutic armamentarium for patients with moderate-to-severe atopic dermatitis who already had an adequate or inadequate response to topical therapy, and we always welcome new additions to treating this difficult to treat patient population.”

Additional data on the biologic confirmed that tralokinumab could be used with or without the aid of topical corticosteroids.

As a monotherapy, the biologic was deemed efficacious in the first 2 ECZTRA trials. However, the third and final ECZTRA trial saw greater efficacy achieved with combination topicals, which Silverberg believed supported the recommendation of using the biologic with topical corticosteroids.

With the recent approval of tralokinumab, Silverberg expressed his excitement with offering his patients the new therapeutic option.

“We look forward to being able to prescribe it to our patients very soon. I think there's more long-term safety data in the real world and observation and all those data are coming,” Silverberg said. “But right now, the thing I look forward to most is getting my hands on it and being able to use it in my patients.”

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