FDA expands teprotumumab indication to include any thyroid eye disease duration, activity
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Key takeaways:
- The FDA issued an update allowing teprotumumab to be used to treat thyroid eye disease of any duration or activity level.
- Teprotumumab reduced proptosis in 62% of adults with long-standing thyroid eye disease.
The FDA approved expanded indication language to allow the use of teprotumumab for the treatment of thyroid eye disease for any level of activity or duration, according to a press release.
The update to the indications and usage section of teprotumumab’s (Tepezza, Horizon Therapeutics) label expands the drug’s use to include all adults with thyroid eye disease, “regardless of thyroid eye disease active or duration.”
The update came days after topline results from a phase 4 trial showed teprotumumab was associated with a greater reduction in proptosis than placebo among adults with long-duration thyroid eye disease and low activity levels. As Healio previously reported, 62% of adults with long-standing thyroid eye disease and low clinical activity scores had a reduction in proptosis of at least 2 mm at 24 weeks. The teprotumumab group had a mean proptosis reduction of 2.41 mm. No new safety signals were observed.
As Healio previously reported, the FDA approved teprotumumab for the treatment of thyroid eye disease in January 2020. The drug previously met its primary endpoints for reducing proptosis among adults with recently diagnosed thyroid eye disease and those with a high clinical activity score in phase 2 and phase 3 trials.
“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,” Tim Walbert, chairman, president and CEO of Horizon Therapeutics, said in a press release. “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."
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