Celgene's Otezla becomes first therapy approved in US for oral ulcers in Behçet's disease

Celgene announced Friday that the FDA has expanded the label for the PDE4 inhibitor Otezla (apremilast) to include treatment of oral ulcers in adults with Behçet's disease. "We are excited to provide the first and only FDA-approved treatment for oral ulcers associated with Behçet's disease," commented Terrie Curran, head of Celgene's inflammation and immunology unit, adding "we remain dedicated to further studying Otezla and its role in inflammatory conditions." 

Approval was based on findings from the Phase III RELIEF trial evaluating Otezla in 207 Behçet's disease patients with active oral ulcers who were previously treated with at least one non-biologic medication and were candidates for systemic therapy. Results demonstrated that Otezla-treated patients achieved a 42.7-point reduction from baseline in the pain of oral ulcers as measured using a visual analogue scale at week 12, compared with an 18.7-point reduction for placebo. In addition, the proportion of patients who were free of oral ulcers at week 12 was 52.9% for those in the Otezla group and 22.3% for the placebo arm. 

RELIEF study results also showed that the proportion of patients on Otezla who achieved an oral ulcer complete response by week six and who remained oral ulcer-free for at least six more weeks during the 12-week treatment phase was 29.8%, versus 4.9% for placebo. Further, the daily average number of oral ulcers during the 12-week treatment phase was 1.5 in the Otezla arm and 2.6 in the placebo group.

Otezla was initially approved in the US in 2014 for the treatment of adults with active psoriatic arthritis and later expanded to include certain patients with moderate-to-severe plaque psoriasis. Sales of the therapy climbed 10% in the first quarter to $389 million. 

Bristol-Myers Squibb agreed to purchase Celgene for $74 billion in January, and announced last month that it would divest Otezla to satisfy competition concerns expressed by the US Federal Trade Commission regarding the proposed merger. 

For related analysis, see ViewPoints: A buyer's guide to Otezla.  

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