Adtralza®▼(tralokinumab) is granted marketing authorisation from MHRA for a new pre-filled pen

PRESS RELEASE

Adtralza^®▼(tralokinumab) is granted marketing authorisation from MHRA for a new pre-filled pen

• The Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorisation for 300 mg of tralokinumab in 2mL solution for injection in a new pre-filled pen, following the European Commission (EU) decision on the 1^st of September 2023.¹

• Tralokinumab is currently available in a 150 mg in 1 mL pre-filled syringe.² Administration with the new 300 mg in 2 mL in the pre-filled pen requires half the number of injections for patients, starting with two initial doses and then a single maintenance dose given every other week, via a hidden needle and press-down auto-injection.³

Maidenhead, Berkshire, UK, 20^th September 2023 – LEO Pharma, a leader in medical dermatology, welcomes the news that the MHRA has granted a marketing authorisation regarding tralokinumab solution for injection with 300 mg in 2 mL pre-filled pen.¹

Tralokinumab is indicated for the treatment of moderate-to-severe atopic dermatitis in adult and adolescent patients 12 years and older who are candidates for systemic therapy.¹ It is a high-affinity fully human monoclonal antibody developed to specifically bind to and inhibit the IL-13 cytokine,⁴ which has previously been available in a 150 mg in 1 ml pre-filled syringe.²

The new 300 mg of tralokinumab in a 2 mL solution in the pre-filled pen will be a simplified method of administration for patients and prescribers, with an initial 600 mg dose in two injections, followed by a single 300 mg maintenance dose given every other week.³ This is rather than four initial, and two maintenance doses with the 150 mg in 1mL pre-filled syringe, halving the number of injections required.² The new pre-filled pen features a hidden needle and a press-down auto-injection with visual and audible feedback mechanisms to aid patients with administration.³

The pre-filled pen will be available in the UK for tralokinumab patients from early 2024.

“We are pleased that this new simplified method of administration for tralokinumab will soon be available for appropriate atopic dermatitis patients in the UK as we strive to advance the standard of care and support for people living with skin conditions,” shared Leanne Walsh, Vice President and General Manager of UK and Ireland at LEO Pharma.

*Ends*

Notes to editors

About atopic dermatitis

Atopic dermatitis is a chronic, inflammatory skin disease characterised by intense itch and eczematous lesions.⁵ Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.⁶ Type 2 cytokines, including IL-13, play an important role in atopic dermatitis pathophysiology.^6,7

About tralokinumab

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.^6,7 Tralokinumab 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

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 4,700 people, serving millions of patients across the world. In 2022, the company generated net sales of EUR 1,430 million.

Contact:

Kate Barwise-Ennis  

Senior Internal and External Engagement Manager 

LEO Pharma  UKIE

+44 7880 740096 

kabar@leo-pharma.com

Sam Coldicutt   

Account Director

WE Communications   

+44 20 7632 3838 

scoldicutt@we-worldwide.com  

References

1. Adtralza^® (tralokinumab) pre-filled pen SmPC. LEO Pharma; September 2023.
2. Adtralza^® (tralokinumab) pre-filled syringe SmPC. LEO Pharma; September 2023.
3. Adtralza^® (tralokinumab) Patient Information Leaflet. LEO Pharma; August 2023.
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. Weidinger S, et al. Atopic dermatitis. 2016;387:1109-1122.
6. Boguniewicz M, et al. Atopic dermatitis: a disease of altered skin barrier and immune dysregulation. Immunol Rev. 2011;242(1):233-46.
7. Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020; 75:54-62.

MAT-67523 September 2023