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

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

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

Shots:

  • 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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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