Scientific approval in EU given to Enstilar (calcipotriol/betamethasone dipropionate) to treat psoriasis vulgaris.-Leo Pharma

LEO Pharma announced that it received scientific approval of Enstilar (calcipotriol/betamethasone dipropionate 50 micrograms/g / 0,5 mg/g) for the treatment of psoriasis vulgaris in patients 18 years of age or older. Enstilar is an alcohol-free foam formulation for the topical treatment for psoriasis vulgaris. Enstilar was developed to treat patients with psoriasis vulgaris – the most common clinical form of psoriasis. In Europe, nearly four million people are living with psoriasis.

The application in the EU decentralized procedure for Enstilar was based on the pivotal Phase IIIa PSO-FAST study which evaluated the efficacy and safety profile across a four week period, and the Phase II MUSE safety profile study. In the PSO-FAST clinical trial, over half of patients treated with Enstilar were “Clear” or “Almost Clear” by Week 4 as measured by the Investigator Global Assessment (IGA) improvement score. Additionally, more than half of patients treated with Enstilar achieved a 75% improvement in Psoriasis Area and Severity Index (PASI) score from baseline.

The scientific approval means that LEO Pharma has received a positive outcome of the decentralized procedure. Receiving this positive outcome is the final step before national marketing authorisations can be granted by the 30 EU countries which are part of the procedure. The national approvals of Enstilar are expected later this year.

Comment: In October 2015, Enstilar was FDA approved for the topical treatment of plaque psoriasis in patients 18 years of age and older.