The U.S. Food and Drug Administration (FDA) has granted Horizon Therapeutics plc (Nasdaq:HZNP) approval to update the Indications and Usage section of the TEPEZZA label, making it the first and only medicine approved for the treatment of Thyroid Eye Disease (TED).
TED is a rare autoimmune disorder that can be progressive, debilitating and potentially threaten vision if left untreated.1 The update specifies that TEPEZZA can now be used to treat TED regardless of its activity or duration.
TEPEZZA has received a label update following the announcement of positive topline results from a Phase 4 clinical trial. This randomized, double-masked, placebo-controlled study showed that patients with an initial diagnosis of thyroid eye disease (TED) between two to 10 years and low disease activity achieved a statistically significant reduction in proptosis from baseline after receiving TEPEZZA compared to those receiving a placebo. With no new safety signals observed, this label update further reinforces TEPEZZA’s potential to improve outcomes in patients with TED.
Horizon is proud to announce the FDA’s approval of a new label for TEPEZZA, its groundbreaking treatment for Thyroid Eye Disease. The new label updates language to emphasize that TEPEZZA can be used to treat all eligible patients, regardless of the activity or duration of the disease. This is a major step forward in the effort to reduce the time it takes for patients to get the treatment they need.
Tim Walbert, Horizon’s chairman, president, and CEO, stressed the importance of unrestricted access for all patients, saying, “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 is excited to unveil the results of their Phase 4 trial at an upcoming medical congress and share the findings with the medical community through a peer-reviewed publication.
About Thyroid Eye Disease (TED)
TED is a severe, degenerative and potentially sight-threatening autoimmune disease that affects a person’s vision. It is typically seen in those with Graves’ disease, but is a distinct entity in its own right.
The disease is caused by autoantibodies activating a complex of IGF-1R signaling in the retro-orbital area, leading to a host of negative repercussions, ranging from dry eyes and grittiness to redness, swelling, excessive tearing, eyelid retraction, pressure and even pain in the eyes. In some cases, long-term damage can occur, including loss of vision.