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Celgene's Otezla becomes first and only FDA-approved therapy for oral ulcers in Behçet’s Disease

Published on 22/07/19 at 10:26am

Celgene has revealed the US approval of Otezla (apremilast), confirming that the FDA awarded marketing authorisation for the treatment of with oral ulcers in adult patients with the rare and chronic inflammatory condition Behçet’s Disease, making it the first and only therapy approved in this indication by the US regulator.

Just around five in 100,000 people are affected by the condition, with painful oral ulcers occurring in 98% of these cases. The approval was supported by Phase 3 data derived from 207 Behçet’s patients with active oral ulcers who were candidates for systemic therapy and had received prior treatment with at least one nonbiologic medication; the data showed that 30mg taken twice daily led to a 42.7% reduction from baseline in oral ulcer pain after 12 weeks compared to 18.7 points with placebo, according to the visual analog scale (VAS).

Additionally, over the same period, 52.9% of patients using Otezla achieved a complete response compared to 22.3% of placebo patients, while the average number of daily oral ulcers during the treatment period was 1.5 with Celgene’s therapy and 2.6 with placebo.

“Behçet’s Disease is a chronic inflammatory disease in which patients present with symptoms such as oral ulcers that can have a significant impact on daily life,” said Dr Mirta Avila Santos, Executive Director of the American Behçet’s Disease Association. “Today’s approval for Otezla marks an important milestone for people with Behçet’s Disease who have been eagerly waiting for treatment options for their oral ulcers.”

Dr Yusuf Yazici, Clinical Associate Professor at the Department of Medicine, New York University Langone Health, also commented: “Oral ulcers are a recurring and debilitating manifestation that affects nearly everyone living with Behçet’s Disease, and have an important negative impact on the quality of life for these patients. In the clinical trial, Otezla demonstrated improvements in measures of oral ulcers at week 12. Otezla has the potential to be a needed treatment option for US patients and their physicians, who previously had limited options available.”

Matt Fellows

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