LEO Pharma Submits New Drug Application for Enstilar® for Adults with Plaque Psoriasis in China

• LEO Pharma is seeking to expand the availability of Enstilar^® (LEO 90100) to China, as the company announces the submission of a New Drug Application (NDA) to the National Medical Products Administration (NMPA).
• The NDA is supported by results from a phase 3 trial comparing the efficacy and safety of Enstilar with Daivobet^® ointment in adult Chinese patients.^1,2
• The Enstilar submission demonstrates LEO Pharma's commitment to providing additional treatment options for the estimated seven million adult patients living with plaque psoriasis in China.³

NOT INTENDED FOR DISTRIBUTION IN THE UK

LEO Pharma A/S, a global leader in medical dermatology, has today announced its submission of a New Drug Application (NDA) to the National Medical Products Administration (NMPA) for Enstilar^® (LEO 90100) to treat adult patients living with plaque psoriasis.

Following a week of significant LEO Pharma treatment and data milestones in the EU and the U.S., today’s news of the NDA submission in China is the latest example of LEO Pharma’s global strategy in action across medical dermatology. If approved, China would join 50 other markets in the world to be approved to bring Enstilar to patients, and would be the largest country to date.

Enstilar^®, a calcipotriol/betamethasone cutaneous foam, is an improved formulation of Daivobet^® ointment, which is one of the current standard treatment options in China for adults living with plaque psoriasis.⁴ Both Daivobet ointment and Enstilar are LEO Pharma products.

“LEO Pharma strives to enhance patient care and elevate quality of life for those living with complex skin conditions like plaque psoriasis,” said Byron Yin, General Manager for LEO Pharma, China. “Today’s submission is a crucial step towards offering a much-needed new treatment option in our region, in addition to the existing portfolio offering from LEO Pharma China.”

“Today’s submission of our NDA for Enstilar is a testament to LEO Pharma’s truly global outlook and ambition in advancing dermatology, following on from a week of milestones across both the EU and U.S.” said Becki Morison, Executive Vice President, Global Product Strategy & International Operations for LEO Pharma. “China is a key market for LEO Pharma, with dermatology growing rapidly in the country and our revenue steadily increasing through a strong performance from our team. We will continue to leverage our extensive dermatology expertise to enhance the treatments we can provide in the region, unwavering in our goal to provide support to those in China that need it most.”

The NDA submission is supported by results from a phase 3 trial comparing the efficacy and safety of a once daily application with Enstilar and Daivobet ointment after 4 weeks of treatment in adult Chinese subjects with stable plaque psoriasis (N=604).^1,2 The trial achieved its primary and secondary endpoints, with Enstilar demonstrating superiority to Daivobet ointment.²

“The trial showed the potential that Enstilar has to improve the quality of life for millions of Chinese patients living with plaque psoriasis,” said Professor Zhang Jianzhong from Peking University People's Hospital, lead investigator of the phase 3 Enstilar trial. “Through today’s milestone, we take a step towards new treatment options for the millions that live with plaque psoriasis in the near future.”

Following the Enstilar submission, the Centre for Drug Evaluation (CDE) will validate the filing, before the full evaluation of the NDA is conducted by the CDE. The regulatory review process is expected to conclude in the first half of 2026.

About Enstilar^®

Enstilar^® is an aerosol spray foam containing calcipotriol monohydrate 50 mcg/g and betamethasone dipropionate 0.5 mg/g. In the EU, it is indicated for the treatment of psoriasis vulgaris in adults for up to 4 weeks. Patients who have responded at 4 weeks’ treatment using Enstilar once daily are suitable for long-term maintenance treatment. ^4-7

About Psoriasis

Psoriasis is a chronic, systemic inflammatory disease that primarily affects the skin in 125 million people worldwide.^8,9 Psoriasis is the result of skin barrier cell proliferation and the activation of cytokines (a family of proteins involved in immune responses) that cause inflammation.¹⁰ About 80% to 90% of patients are affected by plaque psoriasis, the most common clinical form of psoriasis.¹¹ The symptoms of plaque psoriasis are itchy or painful raised scaly and inflamed plaques. Plaques may appear anywhere on the body, but often appear on the scalp, knees, elbows and torso.¹¹

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

1. ClinicalTrials.gov. National Library of Medicine (U.S.). A Study to Investigate Efficacy and Safety With LEO 90100 Compared With Daivobet® Ointment in Adult Chinese Subjects With Stable Plaque Psoriasis. Identifier: NCT05919082. https://clinicaltrials.gov/study/NCT05919082.
2. LEO Pharma Press Release. LEO Pharma Announces Topline Results of Phase 3 Trial in China for Enstilar® (LEO 90100) Demonstrating Superiority in Adult Chinese Subjects With Stable Plaque Psoriasis. Published: May 04, 2024. Last accessed: Sep 25, 2024. Available at: https://www.businesswire.com/news/home/20240507292614/en/LEO-Pharma-Announces-Topline-Results-of-Phase-3-Trial-in-China-for-Enstilar%C2%AE-LEO-90100-Demonstrating-Superiority-in-Adult-Chinese-Subjects-With-Stable-Plaque-Psoriasis.
3. Ding X, Wang T, Shen Y, et al. Prevalence of psoriasis in China: a population-based study in six cities. Eur J Dermatol. 2012;22(5):663-667.
4. Zhang, XJ et al., Chin J Dermatol, July 2023, Vol. 56, No. 7, Guideline for the diagnosis and treatment of psoriasis in China (2023 edition)
5. Enstilar^® EU Summary of Product Characteristics July 2022.
6. Koo J, Tyring S, Werschler WP, et al. Superior efficacy of calcipotriene and betamethasone dipropionate aerosol foam versus ointment in patients with psoriasis vulgaris--A randomized phase II study. J Dermatolog Treat. 2016;27(2):120-127.
7. Leonardi C, et al. Efficacy and Safety of Calcipotriene Plus Betamethasone Dipropionate Aerosol Foam in Patients With Psoriasis Vulgaris—a Randomized Phase III Study (PSO-FAST). J Drugs Dermatol. 2015;14(12):1468-1477.
8. Menter A, Korman NJ, Elmets CA, Feldman SR, Gelfand JM, Gordon KB, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis. Section 3. Guidelines of care for the management and treatment of psoriasis with topical therapies. J Am Acad Dermatol 2009; 60: 643-659.
9. National Psoriasis Foundation. Psoriasis Statistics. Last updated: Dec 21, 2022. Last accessed: Sep 25, 2024. Available at: https://www.psoriasis.org/content/statistics.
10. Hawkes JE, Chan TC, Krueger JG. Psoriasis pathogenesis and the development of novel targeted immune therapies. J Allergy Clin Immunol. 2017;140(3):645-653.
11. National Psoriasis Foundation. Plaque Psoriasis. Last updated: Feb 08, 2024. Last accessed: Sep 25, 2024. Available at: https://www.psoriasis.org/plaque/.

MAT-76612 September 2024

View source version on businesswire.com: https://www.businesswire.com/news/home/20240927735108/en/