Leo Pharma has announced the submission of a regulatory application in China for Enstilar, a topical treatment intended for adult patients suffering from plaque psoriasis. This marks the second application process initiated by the Danish dermatology company this week, underscoring its commitment to expanding its global reach.
The application seeks approval for Enstilar as a treatment for adults with plaque psoriasis, a chronic inflammatory skin disease characterized by raised, red, scaly patches on the skin. The prevalence of psoriasis in China is estimated to be around 0.3%, affecting millions of individuals.
Enstilar is a combination product containing calcipotriol and betamethasone dipropionate. Calcipotriol is a vitamin D analogue that inhibits keratinocyte proliferation and promotes differentiation, while betamethasone dipropionate is a potent corticosteroid with anti-inflammatory and immunosuppressive effects. The combination aims to address both the inflammation and the abnormal skin cell growth associated with psoriasis.
The submission of the application triggers a review process by the Chinese regulatory authorities, who will evaluate the safety and efficacy data supporting Enstilar's use. The decision will be based on clinical trial results and other relevant information. If approved, Enstilar would provide a new treatment option for Chinese patients with plaque psoriasis.
