Phase IV clinical trial of Tepezza confirms efficacy in Thyroid Eye Disease

The totality of clinical trial data continues to strongly support the efficacy of Tepezza across a broad spectrum of TED patients regardless of disease activity or duration, with a well-established safety profile. Tepezza is the first and only medicine approved by the FDA for the treatment of TED – a serious, progressive, debilitating and potentially vision-threatening rare autoimmune disease.

The Phase IV trial evaluated patients with an initial diagnosis of TED between two to 10 years (mean duration of 5.2 years; SD 1.77) and low levels of disease activity (mean CAS of 0.4; SD 0.49), whereas the prior pivotal trials (Phase II and III) that formed the basis of the original FDA approval of Tepezza evaluated patients with disease duration of nine months or less and higher levels of disease activity.

At Week 24, topline data per the pre-specified primary analysis method (intent-to-treat) demonstrated that the primary endpoint was met, and patients treated with Tepezza achieved a statistically significant reduction in proptosis from baseline compared to those receiving placebo. In addition, in the pre-specified per-protocol analysis, the differences between patients treated with Tepezza and patients treated with placebo increased. No new safety signals were observed. The Company plans to present these data at a future medical congress and publish them in a peer-reviewed medical journal.