FDA Approves Adbry® (tralokinumab-ldrm) Autoinjector for the Treatment of Adults with Moderate-to-Severe Atopic Dermatitis (AD)

• Single-dose autoinjector will provide adult patients in the U.S. with an alternative method of administration for Adbry, with the device planned to be available in the coming months.
• The autoinjector device provides a more convenient self-administration option for patients and reduces the number of injections required.¹
• The FDA approval increases the options available for the estimated 6.6 million adults who live with moderate-to-severe atopic dermatitis (AD) in the U.S.²

NOT FOR UK USE – NOT INTENDED FOR UK MEDIA

LEO Pharma Inc. has today announced approval from the U.S. Food and Drug Administration (FDA) for a new Adbry^® (tralokinumab-ldrm) 300 mg single-dose autoinjector for adult patients.¹ Adbry, a high-affinity fully human monoclonal antibody,³ is currently indicated in the U.S. for the treatment of moderate-to-severe atopic dermatitis in patients aged 12 years and older.¹

The new autoinjector will provide another option for adult patients in addition to the pre-filled syringe administration that is currently available. Prior to the introduction of the autoinjector, Adbry was only available in a 1 mL pre-filled syringe. With the new 2 mL autoinjector, adult patients now have a more convenient option with half the number of required injections compared to the 1 mL pre-filled syringe.¹

“We are constantly looking for new ways to advance the standard of care and improve the patient experience for our treatment options,” said Brian Hilberdink, EVP and President, Region North America, LEO Pharma. “Through this latest approval, a new mode of administration has been made available to provide a more convenient option to support self-administration. Our team will now undertake the necessary steps to ensure patients living across the United States have access to this device in the coming months.”

For patients who prefer the pre-filled syringe, this option will continue to be available in the U.S.

“We understand that no patient is the same, and through this extended approval we have taken a positive step forward to equip those living with AD with more choices,” commented Shannon Schneider, Senior Medical Affairs Director, LEO Pharma. “Alongside the previously approved pre-filled syringe, the autoinjector will give adult patients in the U.S more options than ever before in how they administer their treatment.”

In the U.S., Adbry is available in a single-use pre-filled syringe (150 mg/1 mL) as well as a single-use autoinjector (300 mg/2 mL). Adbry received approval from the U.S. FDA in December 2021 for the treatment of moderate-to-severe atopic dermatitis in adults. Subsequently, in December 2023, the indication was expanded to include pediatric patients 12 years and older. The autoinjector received approval in June 2024 for adult patients.

Adbry (tralokinumab-ldrm) is marketed outside of the U.S. under the tradename Adtralza^® (tralokinumab) and 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.

Notes to editors

About atopic dermatitis

Atopic dermatitis is a chronic, inflammatory skin disease characterized by intense itch and eczematous lesions.⁴ Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.⁵ Type 2 cytokines, including IL-13, play an important role in the key aspects of atopic dermatitis pathophysiology.⁶

About Adbry^® (tralokinumab-ldrm)

Adbry^® (tralokinumab-ldrm), which is marketed outside of the U.S. under the tradename Adtralza^® (tralokinumab), is a high-affinity fully 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.⁶ 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).^3,6

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 and autoinjectors.
• 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 prefilled syringe with needle guard or as an autoinjector.
• ADBRY is given as an injection under the skin (subcutaneous injection).
• If your healthcare provider decides that you or a caregiver can give the injections 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. In children 12 years of age and older, it is recommended that ADBRY be given by or under supervision of an adult.
• 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 new or 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 4,200 people, serving millions of patients across the world. In 2023, the company generated net sales of DKK 11.4 billion.

References

1. Adbry^® (tralokinumab-ldrm) Prescribing Information. LEO Pharma; June 2024.
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. 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.
4. Weidinger S, Novak N. Atopic dermatitis. Lancet. 2016;387(10023):1109-1122.
5. Boguniewicz M, Leung DY. Atopic dermatitis: a disease of altered skin barrier and immune dysregulation. Immunol Rev. 2011;242(1):233-246.
6. Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020; 75:54-62.

MAT-74279 June 2024

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