FDA accepts for review Supplemental New Drug Application (sNDA) for apremilast in adults with mild-to-moderate plaque psoriasis
The sNDA is based on data from phase 3 ADVANCE trial (n=595) which demonstrated that apremilast 30 mg twice daily achieved a statistically significant improvement in the primary endpoint of the static Physician's Global Assessment response at week 16 compared to placebo.
Source:
Biospace Inc.
SPS commentary:
Currently, apremilast is only licensed for the treatment of moderate to severe chronic plaque psoriasis in adult patients (after failure to respond to or who have a contraindication to, or are intolerant to other systemic therapy).