Adbry, the first biological treatment launched by LEO Pharma in the United States, is expected to be available in pharmacies in February 2022.

Tralokinumab is marketed outside of the United States under the trade name Adtralza ® and is currently approved in the European Union, Great Britain, Canada, and the United Arab Emirates.LEO Pharma A / S, a world leader in clinical dermatology, has just announced that the United States Food and Drug Administration (FDA) has approved Adbry ™ (tralokinumab) for the treatment of moderate to severe atopic dermatitis in adults 18 years of age and older whose disease cannot be adequately controlled with prescription topical therapies or when these therapies are not advisable. Adbry can be used with or without topical corticosteroids. 1 Adbry is the first and only biologic drug approved by the FDA that specifically binds and inhibits the cytokine IL-13, a determinant of the signs and symptoms of atopic dermatitis. 1,2,3

 

“With the FDA approval of Adbry, today we reached an important milestone in the history of LEO Pharma and the millions of people with moderate to severe atopic dermatitis who are struggling to find an appropriate treatment option for this disease chronic and debilitating, ”said Anders Kronborg, Chief Financial Officer and Acting CEO of LEO Pharma A / S. "As our first biologic drug in the United States, Adbry represents a substantial advance in our mission to advance the standard of care in clinical dermatology."

 

The approval of Adbry is based on the safety and efficacy results of the pivotal phase 3 trials ECZTRA 1, 2 and ECZTRA 3, involving nearly 2,000 adult patients with moderate to severe atopic dermatitis. 1 Safety data were evaluated from a set of five randomized, double-masked, placebo-controlled trials, including ECZTRA 1, 2 and ECZTRA 3, a dose determination trial, and a vaccine response trial. one

 

“Atopic dermatitis can be serious and unpredictable, so it is not only challenging for patients in achieving long-term control, but also for clinicians in treating it, as treatment options for these painful chronic skin diseases are limited, ”said Jonathan Silverberg, MD, PhD, MPH, associate professor of dermatology at the George Washington University School of Medicine and Health Sciences, and investigator of the tralokinumab clinical trial. "Adbry will become an important addition to our therapeutic arsenal as it is a treatment designed to specifically target and neutralize the cytokine IL-13, helping patients with atopic dermatitis to manage their disease."

 

Adbry will be presented in a 150 mg / ml pre-filled syringe for subcutaneous injection with a starting dose of 600 mg followed by 300 mg every two weeks. Adbry can be used with or without topical corticosteroids. 1 The dose of 300 mg every four weeks can be taken as a reference for patients less than 100 kg who achieve healthy or almost healthy skin after 16 weeks of treatment. one

 

To help eligible patients access Adbry, LEO Pharma will introduce the Adbry ™ Advocate ™ program to support US patients at diagnosis and during treatment with Adbry.

 

"For those living with atopic dermatitis, the experience goes beyond the skin and often has an impact on important psychosocial aspects of their lives," said Julie Block, president and CEO of the National Eczema Association. “It is exciting to see that there is a new treatment option for adult patients living with moderate to severe atopic dermatitis. These kinds of therapeutic advances bring much-needed hope to those who have been struggling for years to find an appropriate therapy to ease the burden of this disease.

 

FDA approval marks the fifth global regulatory clearance for tralokinumab in 2021. This drug is marketed outside the United States under the trade name Adtralza ® and is currently approved in the European Union, Great Britain, Canada, and the United Arab Emirates .

 

About the ECZTRA 1, 2, and ECZTRA 3 Core Assays

 

ECZTRA 1 and ECZTRA 2 (ECZema TRAlokinumab trials # 1 and 2) were randomized, double-blind, placebo-controlled, multinational trials of 52 weeks duration, enrolling 802 and 794 adult patients, respectively, to assess efficacy and efficacy. Safety of Adbry (300 mg every other week) as monotherapy in adults with moderate to severe atopic dermatitis who were eligible for systemic therapy. 4

 

ECZTRA 3 (ECZema TRAlokinumab Trial # 3) was a 32-week, multinational, double-blind, placebo-controlled, randomized trial, including a total of 380 adult patients, to evaluate the efficacy and safety of Adbry (300 mg every other week) in combination with topical corticosteroids, as needed, in adults with moderate to severe atopic dermatitis eligible for systemic treatment. 5

 

About atopic dermatitis

 

Atopic dermatitis is a chronic inflammatory skin disease characterized by intense itching and eczematous lesions. 6 Atopic dermatitis is the result of a dysfunction of the skin barrier and immune dysregulation, leading to chronic inflammation. 7 Type 2 cytokines, including IL-13, play a critical role in key aspects of the pathophysiology of atopic dermatitis. LEO Pharma helps people to have healthy skin. The company is a leader in clinical dermatology with a strong R&D product portfolio, a wide range of therapies, and a pioneering spirit. Founded in 1908 and majority controlled by the LEO Foundation, LEO Pharma has dedicated decades of research and development to advancing the science of dermatology, setting new standards of care for people with skin conditions. LEO Pharma is based in Denmark and has an international team of 6,000 people serving 93 million patients in 130 countries. In 2020, the company generated net sales of DKK 10133 million