Supplemental new drug application submitted to FDA seeking expanded approval for apremilast (Otezla) in adults with mild-to-moderate plaque psoriasis

Submission based on phase III ADVANCE trial which reported apremilast 30mg BD achieved statistically significant improvement in primary endpoint of Physician's Global Assessment response vs. placebo at week 16. Currently only approved for moderate/severe chronic plaque psoriasis

Source:

PharmaTimes