The FDA approved apremilast for the treatment of adult patients with oral ulcers associated with Behçet’s disease, a rare chronic multisystem inflammatory disease.
The FDA based its approval on the RELIEF study, a phase 3 randomized, double-blind, placebo-controlled trial evaluating apremilast 30 mg twice daily in patients with Behçet’s disease who were previously treated with at least one topical or systemic medication.
Patients administered apremilast reported a reduction from baseline ulcer pain, as per visual analog scale (VAS) at week 12, versus the 18.7-point reduction reported by patients on placebo.
“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 company press 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.”
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.