Amgen Reports sNDA Submission of Otezla (apremilast) to The US FDA's for Adults with Mild to Moderate Plaque Psoriasis
Shots:
- The sNDA filing is based on P-III ADVANCE trial data- assessing Otezla (30 mg- bid) vs PBO in 595 patients in a ratio (1:1) with mild-to-moderate plaque psoriasis
- The P-III ADVANCE study results: @16wks.- improvement in its 1EPs of sPGA score; achieve 2EPs i.e- 75% improvement in BSA- change in PASI score
- Otezla is a selective PDE4 inhibitor- approved therapy for mod. to sev. plaque psoriasis who are candidates for phototherapy or systemic therapy- for active PsA- and for with oral ulcers associated with Behçet’s Disease
Ref: PRNewswire | Image: Conejo Valley Guide
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