LEO Pharma Receives Positive CHMP Opinion for New Adtralza® (tralokinumab) Injection Device

• CHMP recommends approval of the Adtralza pre-filled pen.
• Adtralza is currently available in a 1 ml pre-filled syringe. Administration with the 2 ml pre-filled pen requires half the number of injections, with a single dose given every other week, and simplifies the process with a hidden needle and press-down auto-injection.
• Following positive opinion from the CHMP, a final decision from the European Commission is pending.

BALLERUP, Denmark--(BUSINESS WIRE)--LEO Pharma A/S, has today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion that recommends the approval of Adtralza^® (tralokinumab) solution for injection in a new single dose (300 mg) 2 ml pre-filled pen.

Adtralza, a high-affinity fully human monoclonal antibody,¹ has previously been available in a 1 ml pre-filled syringe. The 2 ml pre-filled pen will be an additional option for Adtralza patients and prescribers who prefer a simplified method of administration that halves the number of injections required, with a single 300 mg dose given every other week rather than two 150 mg doses with the pre-filled syringe. For patients who prefer the pre-filled syringe, this administration option will continue to be available in markets where Adtralza is already launched.

The pre-filled pen, developed in partnership with a global leader in innovative injection systems, features a hidden needle and a simple press-down auto-injection with visual and audible feedback mechanisms to aid patients with administration.

“Not only will the Adtralza 2 ml pre-filled pen be more convenient by reducing the number of injections required, but it also eases administration by simplifying the injection process for patients,” said Kreesten Meldgaard Madsen, Chief Development Officer, LEO Pharma. “This milestone brings us a step closer to providing the best possible support to patients, caregivers and prescribers in the management of moderate-to-severe atopic dermatitis.”

The CHMP’s positive opinion will be reviewed by the European Commission (EC) and, pending the final decision, authorization of the pre-filled pen will be valid in all EU member states, Iceland, Norway, and Liechtenstein. Regulatory filings in other markets are underway.

Adtralza is approved for the treatment of adult and adolescent patients with moderate-to-severe AD in the European Union, Canada, Great Britain, and the United Arab Emirates, and is approved for use in adults with moderate-to-severe AD in Switzerland, Saudi Arabia, and Japan. In the U.S., Adtralza is marketed under the tradename Adbry^® and is approved for use in adults with moderate to severe AD.

About atopic dermatitis

Atopic dermatitis is a chronic, inflammatory skin disease characterized by intense itch and eczematous lesions.² Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.³ Type 2 cytokines, including IL-13, play an important role in the key aspects of atopic dermatitis pathophysiology.^3,4

About Adtralza^® (tralokinumab)

Adtralza^® (tralokinumab), which is marketed under the tradename Adbry^® in the U.S., 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.^3,4 Adtralza specifically binds to the IL-13 cytokine, thereby inhibiting interaction with the IL-13 receptor α1 and α2 subunits (IL-13Rα1 and IL-13Rα2).¹

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 DKK 10.6 billion.

References

1. 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.
2. Weidinger S, et al. Atopic dermatitis. Lancet. 2016;387:1109-1122.
3. Boguniewicz M, et al. Atopic dermatitis: a disease of altered skin barrier and immune dysregulation. Immunol Rev. 2011;242(1):233-46.
4. Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020; 75:54-62.

MAT-66127 June 2023