Tepezza Approved for Thyroid Eye Disease Regardless of Disease Activity, Duration

The Indications and Usage section of the Tepezza^® (teprotumumab-trbw) prescribing information has been updated to specify its use for the treatment of thyroid eye disease regardless of thyroid eye disease (TED) activity or duration.

In January 2020, the Food and Drug Administration (FDA) approved Tepezza, a human insulin-like growth factor-1 receptor inhibitor, for the treatment of TED in patients who had disease duration of 9 months or less and higher levels of disease activity.

The updated labeling was based on data from a randomized, double-masked, placebo-controlled phase 4 trial (ClinicalTrials.gov Identifier: NCT04583735) that evaluated the efficacy and safety of Tepezza in 62 adults who were diagnosed with TED 2 to 10 years prior to screening and had low levels of disease activity (clinical activity score of ≤1 in both eyes for at least 1 year prior to screening or all of the following 1 year prior to screening: no progression in proptosis, no progression in diplopia and no new inflammatory TED symptoms).

Results from the trial showed that treatment with Tepezza met the primary endpoint demonstrating statistically significant reductions in proptosis at week 24 compared with placebo. Moreover, a greater proportion of proptosis responders were reported in the Tepezza treatment arm compared with the placebo arm (key secondary endpoint). No new safety signals were observed.

“We worked closely with the FDA on this important label update, which further reinforces the potential benefit of Tepezza in people impacted by thyroid eye disease regardless of disease activity or duration,” said Tim Walbert, chairman, president and CEO, Horizon. “While Tepezza already had a broad indication for the treatment of thyroid eye disease, the new indication language now references treatment regardless of disease activity or duration.”

Tepezza is available as a 500mg lyophilized powder in a single-dose vial for intravenous infusion after reconstitution.