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

• Adbry is the first biologic launched by LEO Pharma in the United States and is expected to be available in pharmacies by February 2022.
• Significantly more patients achieved the primary and key secondary endpoints of IGA 0/1, EASI-75, and itch as measured by NRS at Week 16 with Adbry vs placebo.¹
• There are an estimated 16.5 million adults in the U.S. living with atopic dermatitis, with approximately 6.6 million categorized as living with moderate-to-severe disease.²

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 Adbry^TM Advocate^TM 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

• At Week 16, for the ECZTRA 1 and 2 monotherapy trials, respectively, 16% and 21% of patients treated with Adbry 300 mg every other week achieved clear or almost clear skin (IGA 0/1) vs 7% and 9% with placebo.¹
• At Week 16, for ECZTRA 1 and 2, respectively, 25% and 33% of patients treated with Adbry 300 mg every other week achieved an improvement of 75% or more in the Eczema Area and Severity Index score (EASI-75) vs 13% and 10% with placebo.¹
• Additionally, at Week 16, for ECZTRA 1 and 2, respectively, 20% and 25% of patients treated with Adbry 300 mg every other week achieved a reduction of ≥ 4 points in the weekly average Worst Daily Pruritus NRS vs 10% and 9% with placebo.¹
• At 52 weeks, 51% and 60% of patients who responded at Week 16 maintained IGA 0/1 response with Adbry 300 mg every other week in ECZTRA 1 and 2, respectively.¹
• At 52 weeks, 60% and 57% of patients who responded at Week 16 maintained EASI-75 response with Adbry 300 mg every other week in ECZTRA 1 and 2, respectively.¹

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:

• At Week 16, 38% of patients treated with Adbry 300 mg every other week plus TCS achieved clear or almost clear skin (IGA 0/1) vs 27% with placebo plus TCS.¹
• At Week 16, 56% of patients treated with Adbry 300 mg every other week plus TCS achieved an improvement of 75% or more in the Eczema Area and Severity Index score (EASI-75) vs 37% with placebo plus TCS.¹
• Further, at Week 16, 46% of patients treated with Adbry 300 mg every other week plus TCS achieved a reduction of ≥4 points in the weekly average Worst Daily Pruritus NRS vs 35% with placebo plus TCS.¹
• At 32 weeks, 89% and 92% of patients who responded at Week 16 maintained response (IGA 0/1 and EASI-75, respectively) with Adbry 300 mg every other week.¹

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?

• ADBRY^TM (tralokinumab-ldrm) injection is a prescription medicine used to treat adults with moderate-to-severe atopic dermatitis (eczema) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. ADBRY can be used with or without topical corticosteroids.
• It is not known if ADBRY is safe and effective in children.

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:

• have eye problems.
• have a parasitic (helminth) infection.
• are scheduled to receive any vaccinations. You should not receive a “live vaccine” if you are treated with ADBRY.
• are pregnant or plan to become pregnant. It is not known whether ADBRY will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known whether ADBRY passes into your breast milk and if it can harm your baby.

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?

• See the detailed “Instructions for Use” that comes with ADBRY for information on how to prepare and inject ADBRY and how to properly store and throw away (dispose of) used ADBRY prefilled syringes.
• Use ADBRY exactly as prescribed by your healthcare provider.
• Your healthcare provider will tell you how much ADBRY to inject and when to inject it.
• ADBRY comes as a single-dose (150 mg) prefilled syringe with needle guard.
• ADBRY is given as an injection under the skin (subcutaneous injection).
• If your healthcare provider decides that you or a caregiver can give the injection of ADBRY, you or your caregiver should receive training on the right way to prepare and inject ADBRY. Do not try to inject ADBRY until you have been shown the right way by your healthcare provider.
• If you miss a dose, inject the missed dose as soon as possible, then continue with your next dose at your regular scheduled time.
• If you inject more ADBRY than prescribed, call Poison Control at 1-800-222-1222.
• Your healthcare provider may prescribe other medicines to use with ADBRY. Use the other prescribed medicines exactly as your healthcare provider tells you to.

What are the possible side effects of ADBRY?
ADBRY can cause serious side effects including:

• Allergic reactions (hypersensitivity), including a severe reaction known as anaphylaxis. Stop using ADBRY and tell your healthcare provider or get emergency help right away if you get any of the following symptoms:
  • breathing problems
  • itching
  • skin rash
  • swelling of the face, mouth, and tongue
  • fainting, dizziness, feeling lightheaded (low blood pressure)
  • hives
• Eye problems. Tell your healthcare provider if you have any worsening eye problems, including eye pain or changes in vision.

The most common side effects of ADBRY include:

• Eye and eyelid inflammation, including redness, swelling, and itching
• Injection site reactions
• High count of a certain white blood cell (eosinophilia)

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.

References

1. Adbry™ (tralokinumab-ldrm) Prescribing Information. LEO Pharma; December 2021.
2. Chiesa Fuxench ZC, Block JK, Boguniewicz M, et al. Atopic Dermatitis in America Study: A Cross-Sectional Study Examining the Prevalence and Disease Burden of Atopic Dermatitis in the US Adult Population. J Invest Dermatol. 2019;139(3):583-590.
3. Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020; 75:54-62.
4. Popovic B, et al. Structural characterisation reveals mechanism of IL-13-neutralising monoclonal antibody tralokinumab as inhibition of binding to IL-13Rα1 and IL-13Rα2. J Mol Biol. 2017; 429:208–19.
5. Wollenberg A, et al. Tralokinumab for moderate‐to‐severe atopic dermatitis: results from two 52‐week, randomized, double‐blind, multicentre, placebo-controlled phase III trials (ECZTRA 1 and ECZTRA 2). Br J Dermatol. 2021. Mar;184(3):437-449.
6. Silverberg JI, et al. Tralokinumab plus topical corticosteroids for the treatment of moderate‐to‐severe atopic dermatitis: results from the double‐blind, randomized, multicentre, placebo-controlled phase III ECZTRA 3 trial. Br J Dermatol. 2021. Mar;184(3):450-463.
7. Weidinger S, et al. Atopic dermatitis. Lancet. 2016;387:1109-1122.
8. Boguniewicz M, et al. Atopic dermatitis: a disease of altered skin barrier and immune dysregulation. Immunol Rev 2011;242(1):233-46.

MAT-42633 December 2021

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