The approval of Tepezza for adults with thyroid eye disease provides an alternative nonsurgical treatment option that could potentially spare patients from multiple invasive surgeries, Wiley Chambers, M.D., deputy director of the Division of Transplant and Ophthalmology Products in the FDA Center for Drug Evaluation and Research, said in an agency press release. Tepezza, a fully human monoclonal antibody and targeted inhibitor of the insulin-like growth factor-1 receptor, is administered once every three weeks for a total of eight infusions.
Approval was based on data from two studies, one phase 2 and one phase 3, with a total of 170 patients with active thyroid disease. Patients were randomly assigned to Tepezza or placebo. Seventy-one and 83 percent of patients who received Tepezza in study 1 and study 2, respectively, had a reduction in proptosis of greater than 2 mm, compared with 20 and 10 percent of patients who received placebo. Secondary end points were also reached in the phase 3 confirmatory clinical study, OPTIC. At week 24, 67.9 percent of patients treated with Tepezza had a change from baseline of at least one grade in diplopia versus 28.6 percent of those receiving placebo. In an analysis of both trials, 53 percent of patients treated with Tepezza had complete resolution of diplopia versus 25 percent of those receiving placebo.
Approval was granted to Horizon Therapeutics Ireland DAC.