FDA approves Enstilar (calcipotriol/betamethasone dipropionate) for plaque psoriasis- LEO Pharma

Enstilar (calcipotriol/betamethasone dipropionate), from LEO Pharma, has been approved by the FDA for the topical treatment of plaque psoriasis in adults 18 years of age and older.

Approval was based on the pivotal Phase III clinical trial, in which over half of patients treated with Enstilar were "clear" or "almost clear" by Week 4 as assessed by the Investigator Global Assessment (IGA) score of disease severity. Additionally, more than half of patients treated with Enstilar achieved a 75% improvement in Psoriasis Area and Severity Index (PASI) score from baseline, i.e. a PASI 75 response. Adverse reactions were reported in less than 1% of patients treated with Enstilar and included application site irritation, application site pruritus, folliculitis, skin hypopigmentation, hypercalcemia, urticaria, and exacerbation of psoriasis.

In March 2015, LEO Pharma submitted an application for marketing authorisation for Enstilar in plaque psoriasis in the EU.