LEO Pharma Inc. Announces FDA Approval of Enstilar Foam for Plaque Psoriasis


The FDA approved LEO Pharma Inc’s Enstilar for the topical treatment of plaque psoriasis in adults 18 years of age and older.

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, more than half of patients treated with Enstilar were "Clear" or "Almost Clear" by week four as assessed by the Investigator Global Assessment (IGA) score of disease severity. Additionally, more than half of patients treated with Enstilar achieved a 75 percent improvement in Psoriasis Area and Severity Index (PASI) score from baseline.

Adverse reactions were reported in less than one percent 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.”

For more information, visit Enstilar.com.

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