- The single-dose 300 mg/2 mL autoinjector is now available as an additional injection choice when administering Adbry for the treatment of moderate-to-severe atopic dermatitis (AD) in adults.1
- Adult patients now have another convenient self-administration option with the new 300 mg/2 mL autoinjector device, reducing the number of required injections by half compared to the 150mg/1mL pre-filled syringe.1
- An estimated 6.6 million adults live with moderate-to-severe AD in the U.S.2
MADISON, NJ, USA I September 17, 2024 I 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.
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.
SOURCE: LEO Pharma
Post Views: 273
- The single-dose 300 mg/2 mL autoinjector is now available as an additional injection choice when administering Adbry for the treatment of moderate-to-severe atopic dermatitis (AD) in adults.1
- Adult patients now have another convenient self-administration option with the new 300 mg/2 mL autoinjector device, reducing the number of required injections by half compared to the 150mg/1mL pre-filled syringe.1
- An estimated 6.6 million adults live with moderate-to-severe AD in the U.S.2
MADISON, NJ, USA I September 17, 2024 I 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.
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.
SOURCE: LEO Pharma
Post Views: 273
