> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Leo Pharma Gets Updated Prescribing Info for Enstilar
- URL: https://www.fdaweb.com/leo-pharma-gets-updated-prescribing-info-for-enstilar/
- Published: 2020-10-22T12:00:00.000Z
- Updated: 2026-09-14T16:33:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147940

FDA has approved a Leo Pharma supplemental NDA for updated prescribing information for Enstilar (calcipotriene and betamethasone dipropionate) Foam to include data on long-term use in adults with plaque psoriasis. The corticosteroid is approved for the topical treatment of plaque psoriasis in patients 12 years and older.

The submission was based on data from the Phase 3 PSO-LONG clinical trial that evaluated the long-term use of Enstilar Foam in adult patients who achieved treatment success, defined as Physician Global Assessment score of “clear” or “almost clear” with at least a two-grade improvement from baseline, after an initial four-week treatment with the product. “Those treated long-term twice-weekly with Enstilar Foam had a longer time to first loss of response and fewer losses of response than those using vehicle foam,” the company says.

Safety was evaluated based on effects on calcium homeostasis and on hypothalamic-pituitary-adrenal (HPA) axis with long-term use of twice-weekly calcipotriene and betamethasone dipropionate foam, Leo says. “No clinically relevant effects on calcium metabolism or the HPA axis were observed,” it adds.