LEO Pharma Inc. Announces U.S. FDA approval of Adbry® (tralokinumab-ldrm) for the Treatment of Moderate-to-severe Atopic Dermatitis in Pediatric Patients Aged 12-17 Years

• Adbry is the first treatment for pediatric patients with moderate-to-severe atopic dermatitis specifically targeting the interleukin (IL)-13 cytokine, one of the key drivers of atopic dermatitis signs and symptoms.^1,2,3
• There are an estimated 2.4 million pediatric patients aged 12-17 years in the U.S. living with atopic dermatitis, with approximately 1.2 million categorized as living with moderate-to-severe disease.^4,5
• In the ECZTRA 6 trial, significantly more pediatric patients met the primary and key secondary endpoints of IGA 0/1, EASI-75, and itch at Week 16 with Adbry vs placebo.¹

MADISON, N.J.--(BUSINESS WIRE)--NOT INTENDED FOR UK MEDIA

LEO Pharma Inc. today announced that the U.S. Food and Drug Administration (FDA) has expanded the approval of Adbry^® (tralokinumab-ldrm) to include pediatric patients aged 12-17 years with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.¹ Adbry is the first and only FDA-approved biologic that specifically binds to and inhibits the interleukin (IL)-13 cytokine, one of the key drivers of AD signs and symptoms.^1,2,3

"This is an important milestone on our path towards making a fundamental difference for those who need it most. This critical patient group now has access to a much-needed additional treatment option to manage their atopic dermatitis," said Brian Hilberdink, EVP and President, Region North America, LEO Pharma, “We are delighted to be able to offer Adbry, a highly targeted treatment, to both adult and pediatric patients in the U.S. This debilitating disease can have a particularly strong impact on pediatric patients, who often feel socially isolated because of their condition.⁶ We are incredibly proud of the progress we have made to date, and we will continue to work hard to address unmet needs in additional patient populations.”

An initial loading dose of 300 mg, followed by a 150 mg dose every two weeks is approved for U.S. pediatric patients aged 12-17 years.*¹

The approval is based on data from the Phase 3 ECZTRA 6 trial, which evaluated the efficacy and safety of Adbry in 289 pediatric patients aged 12-17 years with moderate-to-severe AD who were candidates for systemic therapy. A total of 98 patients received an initial dose of Adbry 300 mg followed by 150 mg every other week up to Week 16. The trial met its primary and key secondary endpoints¹:

• More than five times as many pediatric patients had clear or almost clear skin with Adbry compared to placebo: 21% of patients who received Adbry achieved an Investigator's Global Assessment (IGA) score of 0 (“clear”) or 1 (“almost clear”) compared to 4% who received placebo.¹
• Approximately five times as many pediatric patients saw a substantial disease improvement with Adbry compared to placebo: 29% of patients who received Adbry achieved at least a 75% improvement in their Eczema Area and Severity Index score (EASI-75) compared to 6% who received placebo.¹
• More than seven times as many pediatric patients experienced significantly reduced itch with Adbry compared to placebo: 23% of patients who received Adbry achieved at least a four-point reduction in Adolescent Worst Pruritis Numerical Rating Scale (NRS) compared to 3% with placebo.¹
• In ECZTRA-6, a higher proportion of pediatric patients who received Adbry achieved at least a 90% improvement in their Eczema Area and Severity Index score (EASI-90) compared to placebo.¹

The safety of Adbry, assessed through the initial treatment period of 16 weeks and the long-term period of 52 weeks, was comparable to the safety profile from trials in adults with atopic dermatitis. In the ECZTRA 1, 2, and ECZTRA 3 adult trials, the most common adverse events (incidence ≥1%) were upper respiratory tract infections (mainly reported as the common cold), conjunctivitis, injection site reactions, and eosinophilia.¹

“We know the symptoms associated with moderate-to-severe atopic dermatitis can have an impact on pediatric patients, which is why it’s so important to have treatment options with demonstrated efficacy in itch reduction and skin clearance,” said Amy Paller, M.D., Chair, Department of Dermatology, Feinberg School of Medicine, Northwestern University in Chicago, the international coordinating investigator for ECZTRA 6. “Clinical trial results that provide this evidence are invaluable to clinicians evaluating the safety and efficacy of treatment options for their pediatric patients.”

LEO Pharma offers the Adbry^® Advocate^™ Program to support eligible patients at diagnosis and through treatment with Adbry. Details about the Adbry Advocate Program are available at 1-844-MYADBRY (1-844-692-3279) or www.ADBRY.com.

“The approval of Adbry for pediatric patients living with moderate-to-severe atopic dermatitis expands the therapeutic options for those living with this disease who historically have had a limited selection to choose from,” said Julie Block, President and CEO of the National Eczema Association. “Such advances in the atopic dermatitis treatment landscape provide much-needed hope for pediatric patients seeking a long-term treatment option that could work for them.”

Dr. Paller is an ECZTRA 6 clinical trial investigator and a paid consultant of LEO Pharma Inc.

About the ECZTRA 6 Trial

ECZTRA 6 is a randomized, double-blind, placebo-controlled, parallel-group, multinational 52-week trial, with 289 patients aged 12-17 years (195 Adbry patients and 94 placebo patients), evaluating the efficacy and safety of Adbry (150 mg or 300 mg) monotherapy compared to placebo in pediatric patients with moderate-to-severe atopic dermatitis who were candidates for systemic therapy.⁷

About atopic dermatitis

Atopic dermatitis is a chronic, inflammatory skin disease characterized by intense itch and eczematous lesions.⁸ Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.⁹ The type 2 cytokine, IL-13, has been identified as a key cytokine in lesional and non-lesional skin and it plays an important role in atopic dermatitis pathophysiology, including immune dysregulation, skin-barrier dysfunction and itch.^2,10

About Adbry^® (tralokinumab-ldrm)

Adbry^® (tralokinumab-ldrm) is a high-affinity human monoclonal antibody developed to bind to and inhibit the interleukin (IL)-13 cytokine, which plays a role in the immune and inflammatory processes underlying atopic dermatitis signs and symptoms.^1,2 Adbry specifically binds to the IL-13 cytokine, thereby preventing the interaction with the IL-13 receptor α1 subunit of the Type 2 receptor and inhibiting the subsequent downstream IL-13 signaling.^3,11

Adbry, which is marketed outside of the U.S. under the tradename Adtralza^® (tralokinumab), is approved for the treatment of adults and pediatric patients (12 years and above) with moderate-to-severe AD in the U.S., Canada, the European Union, the United Arab Emirates, Great Britain, and South Korea. Adtralza is approved for use in adults with moderate-to-severe AD in Saudi Arabia, Switzerland, and Japan.

U.S. INDICATION AND IMPORTANT SAFETY INFORMATION

What is ADBRY?

• ADBRY^® (tralokinumab-ldrm) injection is a prescription medicine used to treat people 12 years of age and older 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 under 12 years of age.

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. There is a pregnancy exposure registry for women who use ADBRY during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. You or your healthcare provider can get information and enroll you in this registry by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/adbry-tralokinumab/.
• 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 -too much ADBRY than prescribed, call your healthcare provider or call Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.
• 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:

• Upper respiratory tract infections
• 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 FDA at 1-800-FDA-1088.

Please click here for full U.S. Prescribing Information, including Patient Information and Instructions for Use.

About LEO Pharma

LEO Pharma is a global company dedicated to advancing the standard of care for the benefit of people with skin conditions, their families and society. 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, and today, the company offers a wide range of therapies for all disease severities. LEO Pharma is headquartered in Denmark with a global team of 4,600 people, serving millions of patients across the world.

For more information, please visit www.leo-pharma.com/.

* Different dosage is approved in Canada, the European Union, the United Arab Emirates, Great Britain, and South Korea (Initially 600 mg, followed by maintenance 300 mg every 2 weeks)

References

1. Adbry^® (tralokinumab-ldrm) Prescribing Information. LEO Pharma; December 2023.
2. Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020; 75:54-62.
3. 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(2):208-219.
4. Silverberg JI, et al. Atopic dermatitis in the pediatric population: A cross-sectional, international epidemiologic study. Ann Allergy Asthma Immunol. 2021;126(4):417-428.e2.
5. US Census data, 2021. Accessed November 8, 2023.
6. Slattery MJ, Essex MJ, Paletz EM, et al. Depression, anxiety, and dermatologic quality of life in adolescents with atopic dermatitis. J Allergy Clin Immunol. 2011;128(3):668-671.
7. Paller AS, et al. Efficacy and Safety of Tralokinumab in Adolescents With Moderate to Severe Atopic Dermatitis: The Phase 3 ECZTRA 6 Randomized Clinical Trial. JAMA Dermatol. 2023;159(6):596-605.
8. Weidinger S, et al. Atopic dermatitis. Lancet. 2016;387:1109-1122.
9. Boguniewicz M, et al. Atopic dermatitis: a disease of altered skin barrier and immune dysregulation. Immunol Rev. 2011;242(1):233-46.
10. Tsoi LC, et al. Atopic dermatitis is an IL-13 dominant disease with greater molecular heterogeneity compared to psoriasis. J Invest Dermatol. 2019;139:1480–1489.
11. Simpson EL, et al. Tralokinumab therapy for moderate-to-severe atopic dermatitis: Clinical outcomes with targeted IL-13 inhibition. Allergy. 2023;78:2875-2891.

MAT-62577 December 2023