LEO Pharma's Enstilar Foam Receives NMPA Approval for Plaque Psoriasis Treatment in China
Key Insights
China's National Medical Products Administration (search) (NMPA) has approved LEO Pharma's Enstilar (calcipotriene/betamethasone dipropionate) foam for treating adult patients with plaque psoriasis (search), expanding access for an estimated 6.5 million Chinese adults living with the condition.
A phase 3 trial with 604 Chinese patients demonstrated Enstilar foam's superiority over Daivobet (search) ointment, achieving primary and secondary endpoints with rapid onset of action and clinically meaningful improvements in quality of life within 2-4 weeks.
The approval strengthens LEO Pharma's position in the world's largest psoriasis (search) market by patient numbers and marks a significant milestone for the company's expansion strategy in China's growing dermatology treatment sector.
China's National Medical Products Administration (search) (NMPA) has approved LEO Pharma's Enstilar (calcipotriene/betamethasone dipropionate) foam for treating adult patients with plaque psoriasis (search), providing a new treatment option for approximately 6.5 million Chinese adults living with the condition. The approval represents a significant milestone for the Danish pharmaceutical company as it expands its presence in the world's largest psoriasis (search) market by patient numbers.
Clinical Trial Results Support Superior Efficacy
The NMPA approval is supported by results from a phase 3 trial comparing Enstilar foam with Daivobet (search) ointment in 604 adult Chinese patients with stable plaque psoriasis (search). The randomized, investigator-blind, active-controlled trial demonstrated that once-daily application of Enstilar foam achieved superiority over the standard-of-care ointment formulation after four weeks of treatment.
The trial met both its primary and secondary endpoints, with Enstilar foam showing statistically significant improvements in key efficacy measures. Patients treated with the foam formulation achieved a 40-50% higher odds of reaching primary and secondary endpoints compared to those receiving the ointment, with odds ratios of 1.4 and 1.5 respectively.
Rapid Onset and Quality of Life Improvements
Clinical data revealed that Enstilar foam demonstrated rapid onset of action, with meaningful improvements observed as early as two weeks into treatment. The foam formulation showed statistically significant reductions in modified Psoriasis (search) Area and Severity Index (mPASI) scores, with approximately 5 percentage points greater improvement compared to the ointment formulation at both week 2 and week 4.
Patient-reported outcomes showed substantial improvements in quality of life measures. The Dermatology Life Quality Index (DLQI) demonstrated approximately 4-point reduction at week 2 and ≥5-point reduction at week 4, representing meaningful improvements that exceed the established minimal clinically important difference of 4 points. These improvements were consistent across patients with mild, moderate, and severe disease at baseline.
"For patients living with plaque psoriasis (search), it means access to a treatment that has been widely adopted in other markets and has become an important part of clinical practice," said Byron Yin, General Manager of LEO Pharma China.
Strategic Market Expansion
The approval positions LEO Pharma to capitalize on China's evolving healthcare landscape and increasing access to innovative treatments. Frederik Kier, EVP of International Operations at LEO Pharma, emphasized that "China is the largest market in terms of patient numbers and represents an important pillar in LEO Pharma's long-term growth strategy."
China joins more than 50 other markets where Enstilar is approved, and the country's large patient population provides a strong foundation for the introduction of both established and future dermatology therapies. The Chinese market is characterized by a growing focus on innovative dermatology treatments, creating opportunities for advanced therapeutic options.
Formulation Advantages Drive Clinical Benefits
Enstilar's aerosol foam formulation allows medication to be applied in an aerated form that spreads easily over the skin, including hair-bearing areas, facilitating even distribution of active ingredients. The innovative formulation provides increased skin bioavailability of active pharmaceutical ingredients compared to traditional ointment formulations.
The foam contains calcipotriol monohydrate 50 mcg/g and betamethasone dipropionate 0.5 mg/g, offering a fixed-dose combination that has become a gold standard for topical treatment of plaque psoriasis (search) in many countries. Clinical studies showed that 33.1% of patients achieved PASI-90 response at week 4, suggesting the treatment may delay or circumvent the need for systemic therapy.
Safety Profile and Treatment Compliance
The safety profile of Enstilar foam was similar to that of the ointment comparator, with a majority of adverse events being mild and not treatment-related. No new safety concerns were identified in the Chinese patient population, consistent with findings from previous international clinical trials.
Treatment compliance in the Chinese trial was high, suggesting that the foam formulation is well-perceived by patients. The rapid improvements in outcomes that matter most to patients are likely to encourage treatment adherence, which is crucial for both initial control of psoriasis (search) signs and symptoms and long-term disease management.
LEO Pharma plans to launch Enstilar in China later this year, building on the company's established leadership in topical psoriasis (search) treatments. The company currently serves close to three million patients worldwide using its psoriasis products, and the Chinese approval strengthens its position in medical dermatology by expanding its portfolio in a strategically important market.