AMGEN INC — Otezla FDA Review (NDA/BLA 205437, 2026)

Report summary

This report details the FDA approval of Amgen's Otezla (apremilast) on July 19, 2019, for oral ulcers associated with Behçet’s Disease (BD), expanding its existing indications for psoriatic arthritis and plaque psoriasis. The approval was based on efficacy and safety data from clinical trials BCT-001 and BCT-002, which evaluated apremilast's impact on oral ulcer pain and response. The report covers trial design, patient demographics, and statistical analysis, confirming a safety profile consistent with prior indications, though adverse events like diarrhea, nausea, and headache were noted. Regulatory reviews also addressed labeling changes, including compliance with the Pregnancy and Lactation Labeling Rule (PLLR), and discussed concerns regarding Behçet’s Syndrome Activity Score (BSAS) and Behçet’s Disease Quality of Life (BD QoL) instruments. Spontaneous pregnancy reports were reviewed, but data remains insufficient to conclude on drug-associated risks during pregnancy.

Key findings — cited to the page