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# Celgene’s Otezla Approved for Oral Ulcers
- URL: https://www.fdaweb.com/celgenes-otezla-approved-for-oral-ulcers/
- Published: 2019-07-19T12:00:00.000Z
- Updated: 2026-09-15T01:39:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144575

FDA has approved a Celgene NDA for Otezla (apremilast) 30 mg twice daily for treating adult patients with oral ulcers associated with Behcet’s Disease. The oral, selective inhibitor of phosphodiesterase 4 was approved based on efficacy and safety results from the Phase 3 RELIEF study evaluating the drug in 207 adult patients with Behcet’s Disease with active oral ulcers who were previously treated with at least one nonbiologic medication and were candidates for systemic therapy. “Results showed Otezla 30 mg resulted in a 42.7 point reduction from baseline in the pain of oral ulcers as measured by the visual analog scale (VAS) at week 12, compared with an 18.7 point reduction with placebo,” the company says. “The proportion of patients achieving an oral ulcer complete response (oral ulcer-free) at week 12 was 52.9% in the Otezla arm and 22.3% in the placebo arm. The proportion of patients achieving oral ulcer complete response by week six and who remained oral ulcer-free for at least six additional weeks during the 12-week treatment phase was 29.8% in the Otezla arm and 4.9% in the placebo arm.