FDA approval of an update to the indication language for Tepezza to specify its use in thyroid eye disease patients regardless of disease activity or duration- Horizon Therapeutics
Horizon Therapeutics plc announced that the 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.
The label update follows positive topline results from a randomized, double-masked, placebo-controlled Phase IV clinical trial (NCT04583735) 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.
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