Horizon Announces FDA Label Update for TEPEZZA

Horizon Therapeutics announced that the FDA has granted approval for an update to the Indications and Usage section of the TEPEZZA label to specify the treatment of "Thyroid Eye Disease regardless of Thyroid Eye Disease activity or duration."

Tepezza is the first and only FDA-approved drug for treating TED - a severe, progressive, and potentially vision-threatening autoimmune disease.

The updated label for TEPEZZA is based on positive topline results from a Phase 4 clinical trial (NCT04583735), which was randomized, double-masked, and placebo-controlled. The results of this trial were announced earlier this week, indicating that patients with TED, who had an initial diagnosis between two to 10 years (with a mean duration of 5.2 years and SD of 1.77) and low disease activity (mean CAS of 0.4; SD 0.49), experienced a statistically significant reduction in proptosis from baseline at Week 24 after receiving TEPEZZA in comparison to those receiving placebo. The trial did not identify any new safety concerns.

“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 chief executive officer, 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. The updated indication reinforces the importance of unrestricted access for all eligible patients across the full spectrum of Thyroid Eye Disease. This creates an opportunity to ease the access burden for patients and physicians with the goal of decreasing time to therapy for patients who may benefit from TEPEZZA.”

The Company plans to present data from the Phase 4 trial at a future medical congress and publish the data in a peer-reviewed medical journal.