LEO Pharma submits Enstilar NDA for plaque psoriasis in China

Leo Pharma has progressed significantly in its efforts to introduce new treatments for plaque psoriasis in China. The pharmaceutical company has recently submitted a New Drug Application (NDA) to China's National Medical Products Administration for Enstilar, a promising treatment aimed at adult patients suffering from plaque psoriasis.

Enstilar is a unique aerosol spray foam that combines calcipotriol and betamethasone. The formulation is an advancement over the existing Daivobet ointment, which is currently a widely accepted treatment in China. The submission of this NDA marks a crucial step for LEO Pharma, following several successful milestones in both the European Union and the United States. If approved, China could emerge as the largest market for Enstilar.

The application is based on the positive outcomes of a Phase III clinical trial that involved 604 adult subjects in China who have stable plaque psoriasis. The trial demonstrated that Enstilar is not only effective but superior to Daivobet ointment, achieving both its primary and secondary endpoints.

The Center for Drug Evaluation (CDE) in China will now undertake the task of validating and thoroughly evaluating the NDA. The entire regulatory review process is expected to conclude in the first half of 2026, providing a timeline for when Enstilar might become available in the Chinese market.

Byron Yin, the General Manager of LEO Pharma China, elaborated on the company's mission and the significance of this submission. "LEO Pharma strives to enhance patient care and elevate the quality of life for those living with complex skin conditions like plaque psoriasis. 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," Yin stated.

Enstilar has already garnered approval in the European Union for up to four weeks of treatment for psoriasis vulgaris in adults. Suitable candidates may also use the treatment for long-term maintenance. This approval in the EU sets a promising precedent for its potential acceptance and success in China.

In addition to Enstilar, LEO Pharma recently achieved another milestone in Europe. The European Commission has given the green light to Anzupgo cream, a new treatment developed by LEO Pharma for adults suffering from moderate to severe chronic hand eczema. This recent approval further underscores LEO Pharma's commitment to addressing various dermatological conditions and improving patient outcomes through innovative treatments.

In summary, LEO Pharma's submission of the NDA for Enstilar represents a significant step towards offering a new and effective treatment for plaque psoriasis in China. Supported by strong clinical trial data and the potential for broad market acceptance, Enstilar could become an essential part of the treatment landscape for psoriasis patients in China by 2026.

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