Celgene’s Otezla (apremilast) Receives FDA’s Approval for Oral Ulcers Associated with Behçet’s Disease

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• The approval is based on P-III RELIEF study results assessing Otezla (30mg, bid) vs PBO in 207 patients in a ratio (1:1) with Behçet’s Disease with active oral ulcers prior treated with at least one nonbiologic medication and systemic therapy for 64wks. across 10 countries
• The P-III RELIEF study results: @12wks. reduction in pain of oral ulcers as measured by the VAS (42.7 vs 18.7); oral ulcer CR (52.9% vs 22.3%); @6wks. oral ulcer CR with oral ulcer-free for at least six additional wks. (29.8% vs 4.9%); the daily average number of oral ulcers (1.5 vs 2.6)
• Otezla is an oral selective inhibitor of phosphodiesterase 4 (PDE4) resulted in increased intracellular cAMP level, indirectly modulating the production of inflammatory mediators with its anticipated PMDA approval in Japan in H2’19

Click here to read full press release/ article | Ref: Celgene | Image: Medical, Marketing and Media