FDA News

FDA approves Otezla for oral ulcers linked to Behçet’s disease

The FDA has approved apremilast 30 mg twice daily for the treatment of adult patients with oral ulcers associated with Behçet’s disease, according to a company press release.

“We are excited to provide the first and only FDA-approved treatment for oral ulcers associated with Behçet’s disease,” Terrie Curran, president of Celgene Inflammation & Immunology, said in the release. “This approval is a reflection of Celgene’s commitment to research in areas of high unmet need, including rare diseases such as Behçet’s disease. We remain dedicated to further studying Otezla and its role in inflammatory conditions.”

The FDA based its approval on data from the RELIEF study, a phase 3 randomized, double-blind, placebo-controlled trial evaluating apremilast 30 mg twice daily in 207 patients with active Behçet’s disease who had been previously treated with at least one topical or systemic medication.

According to study results, 52.9% of patients who received apremilast were oral ulcer-free at 12 weeks, compared with 22.3% of patients who received placebo. In addition, statistically significant improvements were also demonstrated with apremilast in multiple secondary endpoints, including oral ulcer pain (< .0001), overall disease activity (Behçet’s Syndrome Activity Score: < .0001; Behçet’s Disease Current Activity Index: = .0335) and quality of life (= .0003).

“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,” Yusuf Yazici, MD, clinical associate professor of medicine and director of the Behçet’s Syndrome Center at New York University School of Medicine, said in the release. “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 U.S. patients and their physicians, who previously had limited options available.”

According to the FDA, the most common adverse events observed were diarrhea (41.3%), nausea (19.2%), headache (14.4%) and upper respiratory tract infection (11.5%); the safety profile among patients with Behçet’s disease treated with apremilast was consistent with the known safety profile of apremilast. 

The FDA has approved apremilast 30 mg twice daily for the treatment of adult patients with oral ulcers associated with Behçet’s disease, according to a company press release.

“We are excited to provide the first and only FDA-approved treatment for oral ulcers associated with Behçet’s disease,” Terrie Curran, president of Celgene Inflammation & Immunology, said in the release. “This approval is a reflection of Celgene’s commitment to research in areas of high unmet need, including rare diseases such as Behçet’s disease. We remain dedicated to further studying Otezla and its role in inflammatory conditions.”

The FDA based its approval on data from the RELIEF study, a phase 3 randomized, double-blind, placebo-controlled trial evaluating apremilast 30 mg twice daily in 207 patients with active Behçet’s disease who had been previously treated with at least one topical or systemic medication.

According to study results, 52.9% of patients who received apremilast were oral ulcer-free at 12 weeks, compared with 22.3% of patients who received placebo. In addition, statistically significant improvements were also demonstrated with apremilast in multiple secondary endpoints, including oral ulcer pain (< .0001), overall disease activity (Behçet’s Syndrome Activity Score: < .0001; Behçet’s Disease Current Activity Index: = .0335) and quality of life (= .0003).

“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,” Yusuf Yazici, MD, clinical associate professor of medicine and director of the Behçet’s Syndrome Center at New York University School of Medicine, said in the release. “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 U.S. patients and their physicians, who previously had limited options available.”

According to the FDA, the most common adverse events observed were diarrhea (41.3%), nausea (19.2%), headache (14.4%) and upper respiratory tract infection (11.5%); the safety profile among patients with Behçet’s disease treated with apremilast was consistent with the known safety profile of apremilast.