The FDA has approved an update to the indications and usage section of the Tepezza (Horizon Therapeutics plc), specifying its use for the treatment of thyroid eye disease (TED).
Give me a refresh on Tepezza.
Approved by the FDA in 2020, Tepezza is the first and currently only treatment indicated for the treatment of TED.
The recommended dosage consists of a 10 mg/kg intravenously injected into the arm followed by a second 20 mg/kg injection every 3 weeks for 7 additional infusions.
Didn’t we just hear an update on it?
Yes! Last week, Horizon Therapeutics reported positive data from a randomized, double-masked, placebo-controlled phase 4 study (NCT04583735) assessing Tepezza for adult patients with chronic/low clinical activity score (CAS) thyroid eye disease (TED).
See the results here.
So what’s this update about?
The update to Tepezza’s indications and usage section specifies its use for the treatment of TED regardless of the disease’s activity or duration.
Significance?
According to Tim Walbert, Horizon’s chairman/president/CE, this updated indication “reinforces the importance of unrestricted access for all eligible patients across the full spectrum of [TED].”
He added: “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.”
This article has been corrected as of 5/1. Tepezza is intravenously administered via the arm, not the eye.