MADISON, N.J.--(BUSINESS WIRE)--LEO Pharma Inc. announced today the availability of the Adbry® (tralokinumab-ldrm) 300 mg/2 mL single-dose autoinjector in the United States. Adbry is currently indicated in the U.S. for patients 12 years and older 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
Prior to the introduction of the autoinjector device, Adbry was only available in a 150mg/1mL pre-filled syringe. With the new 300 mg/2 mL autoinjector device, adult patients now have another convenient option and half the number of required injections compared to the 150 mg/1 mL pre-filled syringe.1
“I understand from discussions with my patients that living with AD already brings a wide range of difficulties and debilitating factors that need to be managed on a daily basis, so it is integral that any treatment solution is more convenient to manage for those living with the condition, and does not add even more of a burden,” said Jonathan Silverberg, M.D., Ph.D., Professor of Dermatology, of George Washington University. “This new administration option reduces the number of injections required overall and provides adults living with AD with an additional option in how they manage their condition.”
For patients who prefer the pre-filled syringe, this option will continue to be available in the U.S. for both adults and pediatric patients (age 12-17).
“We are proud to expand the administration options for Adbry and the choices available for those adults who are living with AD,” said Brian Hilberdink EVP and President, Region North America, LEO Pharma. “Today’s news supports our goal to help improve the standard of care for those living with skin diseases and highlights our commitment to innovation. We will continue to work tirelessly to improve the treatment options available for various skin conditions in the U.S.”
In the U.S., Adbry is available in a 150 mg/1 mL single-use pre-filled syringe as well as a 300 mg/2 mL single-use autoinjector. For adults, Adbry is administered with an initial loading dose of 600 mg (four injections with prefilled syringe or two injections with autoinjector) followed by a maintenance dose of 300 mg dose every two weeks (two injections with prefilled syringe or one injection with the autoinjector). Adbry adult patients have the flexibility to take a single monthly dose (300 mg/2 mL every 4 weeks) for those who achieve clear or almost clear skin after 16 weeks and weigh<220 pounds.
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, Saudi Arabia and South Korea. Adtralza is approved for use in adults with moderate-to-severe AD in Switzerland, and Japan.
About atopic dermatitis
Atopic dermatitis is a chronic, inflammatory skin disease characterized by intense itch and eczematous lesions.3,4 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.5 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
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
- Adbry® (tralokinumab-ldrm) Prescribing Information. LEO Pharma; June 2024.
- 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.
- 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.
- Weidinger S, Novak N. Atopic dermatitis. Lancet. 2016;387(10023):1109-1122.
- Boguniewicz M, Leung DY. Atopic dermatitis: a disease of altered skin barrier and immune dysregulation. Immunol Rev. 2011;242(1):233-246.
- Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020; 75:54-62.
MAT-76307 September 2024
