Japan Ministry of Health, Labor and Welfare Approves Manufacturing and Marketing of Adtralza� (tralokinumab) in Japan for Adults with Atopic Dermatitis

BALLERUP, Denmark–(BUSINESS WIRE)–LEO Pharma A/S, a global leader in medical dermatology, announced today that the Japan Ministry of Health, Labor and Welfare (MHLW) has granted approval for the manufacturing and marketing of Adtralza^� (tralokinumab) subcutaneous injection (S.C.) for adults with atopic dermatitis, which has inadequately responded to conventional therapies.

“Today’s approval is a significant advancement for those patients in Japan who continue to suffer from the often-debilitating symptoms of atopic dermatitis and are in need of a new treatment option to manage their chronic condition,” said Kook Hyun Son, General Manager of LEO Pharma K.K. “We have made substantial investments in our infrastructure, including the hiring of dedicated medical staff to ensure dermatologists receive the latest Adtralza clinical information to help inform treatment decisions for their patients.”

Adtralza is the first and only approved human, monoclonal antibody developed to specifically target and neutralize the IL-13 cytokine, which plays a key role in the immune and inflammatory process which are the underlying causes of atopic dermatitis signs and symptoms.^1,2 The MHLW has approved Adtralza to be administered as a subcutaneous injection in adults with an initial dose of 600mg, followed by a 300mg dose given every other week.

“The Japan approval is a demonstration of our strategy to expand the availability of Adtralza to millions of patients around the world who are faced with the daily challenges of living with chronic and often debilitating symptoms of atopic dermatitis,” said Becki Morison, executive vice president of global strategy and international operations, LEO Pharma A/S. “We continue to evaluate regulatory filings in markets where there is the greatest need to help ensure patients who may benefit from Adtralza will have access to this biologic therapy.”

The approval is based on results from the global pivotal trials ECZTRA 1, 2, and 3,^3,4 the Japanese pivotal trial ECZTRA 8⁵, and the global open-label extension trial ECZTEND. ^6,7

About the ECZTRA 8 trial

ECZTRA 8 was a 16-week, double-blind, randomized, placebo-controlled phase 3 study in Japanese patients. The study evaluated the efficacy and safety of tralokinumab (300 mg) in combination with TCS in 106 adult patients with atopic dermatitis who were candidates for systemic therapy having an inadequate response to existing therapy.⁵

About the ECZTEND – long-term extension (LTE) trial

ECZTEND (Long-term Extension Trial in Subjects With Atopic Dermatitis Who Participated in Previous tralokinumab Trials) is an ongoing Phase 3, long-term five-year, open-label, single-arm

extension trial to evaluate the efficacy and safety of tralokinumab in patients with atopic dermatitis who participated in the previous tralokinumab monotherapy trials (ECZTRA 1 and ECZTRA 2), the combination therapy tralokinumab plus TCS trial (ECZTRA 3), the Drug-drug interaction (DDI) trial (ECZTRA 4), the vaccine trial (ECZTRA 5), the adolescent trial (ECZTRA 6), the oral cyclosporine A trial (ECZTRA 7), the combination therapy tralokinumab plus TCS trial in Japanese subjects (ECZTRA 8), and the tralokinumab monotherapy skin barrier function trial (TraSki). Patients were permitted to enter ECZTEND after completion of the parent trial regardless of their treatment response or whether they were treated with tralokinumab or placebo.^6,7

About atopic dermatitis

Atopic dermatitis is a chronic, inflammatory, skin disease characterized by intense itch and eczematous lesions.⁸ Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.⁹ Type 2 cytokines, including IL-13, play a central role in the key aspects of atopic dermatitis pathophysiology.²

About Adtralza^® (tralokinumab)

Tralokinumab is a human monoclonal antibody developed to specifically neutralize the IL-13 cytokine. Tralokinumab specifically binds to the IL-13 cytokine with high affinity, thereby inhibiting interaction with the IL-13 receptor ?1 and ?2 subunits (IL-13R?1 and IL-13R?2).^1,2

Adtralza® / Adbry™ (tralokinumab-ldrm) is approved for the treatment of adults with moderate-to-severe AD in the European Union, United States, Great Britain, Canada, the United Arab Emirates, and Switzerland.

About LEO Pharma A/S

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 5,200 people, serving millions of patients across the world. In 2021, the company generated net sales of DKK 9,957 million.

About LEO Pharma K.K. (Japan)

LEO Pharma K.K. was established in June 2010 as a wholly owned Japanese corporation of LEO Pharma A/S in Denmark. LEO Pharma K.K. is conducting business activities to establish a solid position in Japan as a specialty pharmaceutical company specializing in dermatology. For more information, please visit http://www.leo-pharma.jp/.

References

1. Popovic B, et al. Structural characterisation reveals mechanism of IL-13-neutralising monoclonal antibody tralokinumab as inhibition of binding to IL-13R?1 and IL-13R?2. J Mol Biol. 2017; 429:208–19.
2. Bieber T. Interleukin-13: Targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020;75:54–62.
3. Wollenberg A, et al. Tralokinumab for moderate?to?severe atopic dermatitis: results from two 52?week, randomized, double?blind, multicentre, placebo?controlled phase III trials (ECZTRA 1 and ECZTRA 2). Br J Dermatol. 2021; 437-449.
4. Silverberg JI, et al. Tralokinumab plus topical corticosteroids for the treatment of moderate?to?severe atopic dermatitis: results from the double?blind, randomized, multicentre, placebo?controlled phase III ECZTRA 3 trial. Br J Dermatol. 2021; 450-463.
5. ClinicalTrials.gov Identifier: NCT04587453
6. Blauvelt et. al. Two-year Maintenance of Response with Tralokinumab in Moderate-to-Severe Atopic Dermatitis: Interim Analysis of the ECZTEND Open-label Extension Trial. European Academy of Dermatology and Venereology (EADV). Sept 29-Oct 2, 2021. On-demand video oral presentation FC01.04.
7. EU Clinical Trials Register. Long-term extension trial in subjects with atopic dermatitis who participated in previous tralokinumab trials – ECZTEND. EudraCT number: 2018-000746-19. https://www.clinicaltrialsregister.eu/ctr-search/trial/2018-000746-19/GB.
8. Weidinger S, et al. Atopic dermatitis. Lancet. 2016; 387:1109-1122.
9. Boguniewicz M, et al. Atopic dermatitis: a disease of altered skin barrier and immune dysregulation. Immunol Rev. 2011;242(1):233-46.

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Contacts

LEO Pharma A/S Global Media Contact:
David Patti

DAPAI@leo-pharma.com
+1.973.796-7706

Henrik Heskjær

HDTDK@leo-pharma.com
+45 3140 6180

LEO Pharma K.K. Japan Media contact:
LeoPharma_JP@golin.com
080.6628.1955