19 July 2019 - With this third indication in the US, Otezla is the first and only treatment approved for oral ulcers associated with Behçet’s disease.

Celgene Corporation today announced that the U.S. FDA has approved Otezla (apremilast) 30 mg twice daily for the treatment of adult patients with oral ulcers associated with Behçet’s disease. Otezla, an oral, selective inhibitor of phosphodiesterase 4, is the first and only approved treatment option for oral ulcers associated with Behçet’s disease, a rare, chronic, multi-system inflammatory disease that is difficult to treat.

The FDA approval was based on efficacy and safety results from the randomised, placebo-controlled, double-blind Phase 3 RELIEF study evaluating Otezla in 207 adult patients with Behçet’s disease with active oral ulcers who were previously treated with at least one non-biologic medication and were candidates for systemic therapy.

Read Celgene press release