FDA Approves First Oral Treatment for All Psoriasis Severities

On December 21, 2021, the U.S. Food and Drug Administration (FDA) extended the approval of Otezla® (apremilast) for the treatment of adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy, now including those individuals who have mild or moderate plaque psoriasis severity.1 

Otezla® is an oral medication which works by inhibiting phosphodiesterase 4 specific for cyclic adenosine monophosphate (cAMP). With this expanded indication, Otezla® is now the first (and only) oral treatment approved in adult patients across all psoriasis severities.1 

This expanded approval is based on findings from the Phase 3 ADVANCE trial, which found that that 5-times as many adults with mild-to-moderate plaque psoriasis achieved a Static Physician's Global Assessment (sPGA) response (defined as a sPGA score of clear [0] or almost clear [1] with at least a 2-point reduction from baseline) at week 16 compared to placebo. In addition, improvements were seen in Whole Body Itch Numeric Rating Scale response and Scalp Physicians Global Assessment.1

Previously, Otezla® was approved for moderate-to-severe plaque psoriasis, active psoriatic arthritis, and for oral ulcers associated with Behcet’s Disease.