LEO Pharma Takes Significant Step for Psoriasis Treatment in China
LEO Pharma Submits New Drug Application for Enstilar
LEO Pharma A/S, a prominent entity in the medical dermatology field, has announced a pivotal move with the submission of a New Drug Application (NDA) to the National Medical Products Administration (NMPA) for Enstilar (LEO 90100). This application targets adult patients grappling with plaque psoriasis.
Global Strategy in Action
This latest NDA submission is part of LEO Pharma's overarching global strategy aimed at enhancing the treatment landscape in medical dermatology. Following significant treatment and data milestones achieved in the European Union and the United States, this action illustrates LEO Pharma's commitment to providing effective therapies to patients around the globe. With the potential approval of Enstilar, China would join a network of over 50 countries where this treatment is being made available, marking its position as the largest market so far.
Enstilar: Revolutionizing Psoriasis Treatment
Enstilar is a reformulated cutaneous foam consisting of calcipotriol and betamethasone, simplifying treatment options for adults facing plaque psoriasis. The existing treatment in China, Daivobet ointment, is a standard option; however, Enstilar provides an improved delivery system.
Quotes from LEO Pharma Leadership
“LEO Pharma strives to enhance patient care and elevate the quality of life for those dealing with complex skin conditions like plaque psoriasis,” expressed Byron Yin, General Manager for LEO Pharma in China. “This submission is a crucial step towards offering a much-needed new treatment option in our region.”
Becki Morison, Executive Vice President at LEO Pharma, added, “Today’s NDA submission underscores LEO Pharma’s global outlook. China represents a key market where dermatology is experiencing rapid growth, and we are dedicated to leveraging our expertise to enhance treatment options.”
Phase 3 Trial Results Support Submission
The application for Enstilar is backed by compelling results from a phase 3 trial, which evaluated both efficacy and safety through a once-daily application over four weeks. This comprehensive trial included 604 adult subjects from China living with stable plaque psoriasis, and the results have shown Enstilar's superior efficacy over the traditional Daivobet ointment.
Expert Insights on Enstilar's Promise
Professor Zhang Jianzhong from Peking University People's Hospital, who led the phase 3 trial, remarked on the significant potential of Enstilar to enhance the quality of life for patients living with this chronic condition: “With this milestone, we are taking a step toward providing new treatment options for millions affected by plaque psoriasis.”
Regulatory Process and Anticipated Outcomes
Upon submitting the NDA, the Centre for Drug Evaluation (CDE) will conduct a thorough validation before proceeding with a detailed evaluation. The regulatory review process is expected to be concluded by 2026, which suggests an optimistic outlook for the introduction of this therapeutic option to the market.
Understanding Enstilar
Enstilar is an innovative aerosol foam that combines calcipotriol and betamethasone, creating an effective treatment for psoriasis vulgaris. The medication is typically administered for a 4-week duration, with patients showing satisfactory response eligible for longer maintenance therapy.
Psoriasis: A Persistent Challenge
Plaque psoriasis is a chronic inflammatory disorder affecting approximately 125 million people globally. It involves the accelerated proliferation of skin cells resulting in raised, itchy plaques. This condition most commonly manifests on the scalp, elbows, knees, and torso.
About LEO Pharma
Founded in 1908 and majority owned by the LEO Foundation, LEO Pharma has continuously advanced dermatological science through decades of research and innovation. They are dedicated to improving the quality of care for individuals living with skin conditions and offer a wide array of therapies suited for various severity levels. With a team of 4,200 professionals, LEO Pharma positively impacts millions of patients globally, reporting impressive net sales.
Frequently Asked Questions
What is Enstilar?
Enstilar is a calcipotriol and betamethasone aerosol foam designed to treat plaque psoriasis, especially for adults.
Why is Enstilar significant for patients in China?
Enstilar offers an effective new treatment option for adults with plaque psoriasis, contributing to better management of this chronic condition.
What were the results of the Enstilar phase 3 trial?
The phase 3 trial showed that Enstilar was more effective than Daivobet ointment, achieving all primary and secondary endpoints.
What does the NDA submission mean for the timeline of Enstilar's approval?
The NDA submission starts the regulatory process, with the review expected to conclude in the first half of 2026.
How does psoriasis affect patients’ daily lives?
Psoriasis can lead to discomfort, embarrassment, and challenges in daily activities due to its visible and chronic nature.
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