LEO Pharma Inc., a wholly owned U.S. subsidiary of LEO Pharma A/S, announced today that Enstilar® has been approved by the U.S. Food and Drug Administration (FDA) 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 J. Osborne, President and CEO of LEO Pharma Inc. "We are excited about the approval of Enstilar® as it represents another step in LEO Pharma's unwavering commitment to helping patients living with this chronic, often debilitating disease."
Enstilar® is 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 3 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.
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 exacerabation of psoriasis.
"For the vast majority of plaque psoriasis patients using topical therapies as a first-line treatment option, having a therapy that can safely and effectively treat their symptoms is key," said Dr. Craig Leonardi, a Clinical Professor of Dermatology at St. Louis School of Medicine and the lead investigator of the clinical trial. "The approval of Enstilar® provides patients living with plaque psoriasis a new topical treatment option that was shown to be more effective than the ointment fixed combination and the individual components used alone."
SOURCE LEO Pharma Inc.