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Published On: Dec 28, 2021
Last Updated On: Dec 28, 2021
December 28, 2021 06:00 AM Eastern Standard Time
MADISON, N.J.–(BUSINESS WIRE)–LEO Pharma Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Adbry™ (tralokinumab-ldrm) for the treatment of moderate-to-severe atopic dermatitis in adults 18 years or older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Adbry can be used with or without topical corticosteroids.1 Adbry is the first and only FDA approved biologic that specifically binds to and inhibits the IL-13 cytokine, a key driver of atopic dermatitis signs and symptoms.1,3,4
“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,” said Anders Kronborg, Chief Financial Officer and Acting Chief Executive Officer of LEO Pharma A/S. “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 of Adbry is based on safety and efficacy results from the ECZTRA 1, 2 and ECZTRA 3 pivotal Phase 3 trials, which included nearly 2,000 adult patients with moderate-to-severe atopic dermatitis.1 Safety data was evaluated from a pool of five randomized, double-blind, placebo-controlled trials, including ECZTRA 1, 2 and ECZTRA 3, a dose-finding trial, and a vaccine response trial.1
In all three pivotal trials, Adbry 300 mg every other week alone or with topical corticosteroids (TCS) as needed met the primary endpoints at Week 16 as measured by an Investigator Global Assessment score of clear or almost clear skin (IGA 0/1) and/or at least a 75% improvement in the Eczema Area and Severity Index score (EASI-75), and the secondary endpoint of reduction of weekly average Worst Daily Pruritus NRS of ≥ 4 points on the 11-point itch NRS.1
In clinical trials, the safety of Adbry was well established with an overall frequency of adverse events comparable with placebo.1 The most common adverse events (incidence ≥1% and greater than placebo) were upper respiratory tract infections (mainly reported as common cold), conjunctivitis, injection site reactions, and eosinophilia.1
“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,” said Jonathan Silverberg, MD, PhD, MPH, Associate Professor of Dermatology at George Washington University School of Medicine and Health Sciences, and tralokinumab clinical trial investigator. “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.”
Adbry will be available in a 150 mg/mL prefilled syringe for subcutaneous injection with an initial dose of 600 mg followed by 300 mg every other week. Adbry can be used with or without TCS. 1 A dosage of 300 mg every four weeks may be considered for patients below 100 kg who achieve clear or almost clear skin after 16 weeks of treatment.1
To help eligible patients have access to Adbry, LEO Pharma will introduce the AdbryTM AdvocateTM Program to support U.S. patients at diagnosis and throughout treatment with Adbry. Details about the Adbry Advocate Program will be available at 1-844-MYADBRY (1-844-692-3279) or www.ADBRY.com.
“For people living with atopic dermatitis, the experience goes beyond the skin, often impacting important psychosocial aspects of their life,” said Julie Block, President and CEO of the National Eczema Association. “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 an effective therapy to alleviate the burden of this disease.”
The FDA approval marks the fifth global regulatory approval for tralokinumab in 2021. Tralokinumab is marketed outside of the U.S. under the tradename Adtralza® and is currently approved in the European Union, Great Britain, Canada and the United Arab Emirates.
About the pivotal ECZTRA 1, 2 and ECZTRA 3 Trials
ECZTRA 1 and ECZTRA 2 (ECZema TRAlokinumab trials Nos. 1 and 2) were randomized, double-blind, placebo-controlled, multinational 52-week trials, which included 802 and 794 adult patients, respectively, to evaluate the efficacy and safety of Adbry (300 mg every other week) as monotherapy in adults with moderate-to-severe atopic dermatitis who were candidates for systemic therapy.5
ECZTRA 3 (ECZema TRAlokinumab trial No. 3) was a double-blind, randomized, placebo-controlled, multinational 32-week trial, which included 380 adult patients, to evaluate the efficacy and safety of Adbry (300 mg) in combination with TCS as needed in adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapy.6
In the ECZTRA 3 Adbry plus TCS as needed combination trial:
About atopic dermatitis
Atopic dermatitis is a chronic, inflammatory, skin disease characterized by intense itch and eczematous lesions.7 Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.8 Type 2 cytokines, including IL-13, play a central role in the key aspects of atopic dermatitis pathophysiology.3
About Adbry™ (tralokinumab-ldrm)
Adbry (tralokinumab-ldrm) is a human monoclonal antibody developed to specifically neutralize the IL-13 cytokine, which plays a key role in the immune and inflammatory processes underlying atopic dermatitis signs and symptoms. Adbry specifically binds to the IL-13 cytokine, thereby inhibiting interaction with the IL-13 receptor α1 and α2 subunits (IL-13Rα1 and IL-13Rα2).3,4
INDICATION AND IMPORTANT SAFETY INFORMATION
What is ADBRY?
Do not use ADBRY if you are allergic to tralokinumab or to any of its ingredients.
What should I discuss with my healthcare provider before starting ADBRY?
Tell your healthcare provider about all your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How should I use ADBRY?
What are the possible side effects of ADBRY?
ADBRY can cause serious side effects including:
The most common side effects of ADBRY include:
These are not all the possible side effects of ADBRY. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Please click here for full Prescribing Information, including Patient Information and Instructions for Use.
About LEO Pharma
LEO Pharma helps people achieve healthy skin. The company is a leader in medical dermatology with a robust R&D pipeline, a wide range of therapies and a pioneering spirit. Founded in 1908 and majority owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, setting new standards of care for people with skin conditions. LEO Pharma is headquartered in Denmark with a global team of 6,000 people, serving 93 million patients in 130 countries. In 2020, the company generated net sales of DKK 10,133 million.
For more information, please visit www.LEO-Pharma.us.
Multimedia gallery available at LEOPharmaUSMedia.com.
Dr. Silverberg is a paid consultant for LEO Pharma.
MAT-42633 December 2021
LEO Pharma, Global Product Communications