Apremilast Approved for All Plaque Psoriasis Severities

The FDA announced approval of apremilast for all adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy, regardless of disease severity.

The approval was based on findings form the ADVANCE trial, a phase 3 study of adults with mild to moderate plaque psoriasis. Patients received oral apremilast 30 mg twice daily, and the primary endpoint was static Physician Global Assessment (sPGA) response at week 16. At that time, 21.6% of patients achieved an improvement in sPGA vs only 4.1% for patients receiving placebo. Further, scalp psoriasis saw a statistically significant improvement (44% vs 16.6%), with response maintained through week 32.

Stacie Bell, PhD, chief scientific and medical officer at the National Psoriasis Foundation, commented that this latest FDA approval was “welcome news to finally have an oral systemic option with a well-established safety profile available for all adult plaque psoriasis patients.”

Reference
FDA approves OTEZLA^® (apremilast) for the treatment of adult patients with plaque psoriasis, regardless of severity level. Press release. Amgen; December 20, 2021. Accessed December 20, 2021. https://prnmedia.prnewswire.com/news-releases/fda-approves-otezla-apremilast-for-the-treatment-of-adult-patients-with-plaque-psoriasis-regardless-of-severity-level-301448542.html