Horizon: FDA OKs Label for Use in Thyroid Eye Disease

 Horizon Therapeutics plc (Nasdaq: HZNP) today announced that the U.S. Food and Drug Administration (FDA) has approved an update to the Indications and Usage section of the TEPEZZA label to specify its use for the treatment of “Thyroid Eye Disease regardless of Thyroid Eye Disease activity or duration.” 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.¹

The label update follows positive topline results from a randomized, double-masked, placebo-controlled Phase 4 clinical trial (NCT04583735) that were announced earlier this week, which demonstrated that patients with an initial diagnosis of TED between two to 10 years (mean duration of 5.2 years; SD 1.77) and with low disease activity, or CAS, (mean CAS of 0.4; SD 0.49) achieved a statistically significant reduction in proptosis from baseline at Week 24 after receiving TEPEZZA compared to those receiving placebo. In the trial, no new safety signals were observed.

https://www.biospace.com/article/releases/horizon-therapeutics-plc-announces-fda-approval-of-an-update-to-the-indication-language-for-tepezza-teprotumumab-trbw-to-specify-its-use-in-thyroid-eye-disease-ted-patients-regardless-of-disease-activity-or-duration/