FDA approval for LEO Pharma's Enstilar

Danish drugmaker LEO Pharma said today that its Enstilar (calcipotriene/betamethasone dipropionate) foam has been approved by the US Food and Drug Administration for the topical treatment of plaque psoriasis in adults 18 years of age and older.

"The approval of Enstilar may offer the appropriate plaque psoriasis patients a new treatment option in an elegant vehicle that provides rapid relief from symptoms," said Barbara Osborne, president and chief executive of US subsidiary LEO Pharma Inc.

Enstilaris a once-daily, alcohol free foam formulation in a pressurized spray can that allows application across large body areas of plaque psoriasis. In the pivotal Phase III clinical trial, 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. A regulatory application for Enstilar was filed in Europe in March.