HZNP - Horizon announces FDA label update for thyroid eye disease therapy

2023-04-14 08:47:02 ET

• Horizon Therapeutics ( NASDAQ: HZNP ) announced Friday that the FDA approved an update to the labeling information of the company's thyroid eye disease (TED) therapy Tepezza related to its indications and usage.
• Accordingly, the FDA has cleared Tepezza use for "Thyroid Eye Disease regardless of Thyroid Eye Disease activity or duration," HZNP, which struck a buyout deal with Amgen ( AMGN ) late last year, said.
• "The updated indication reinforces the importance of unrestricted access for all eligible patients across the full spectrum of Thyroid Eye Disease," Chief Executive of Horizon ( HZNP ) Tim Walbert remarked.
• The label update comes after the company announced topline data from a Phase 4 trial for Tepezza in TED early this week, noting that the trial reached the primary endpoint with a statistically significant reduction in TED symptom proptosis.

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