Subcutaneous TEPEZZA meets primary endpoint in Phase 3 thyroid eye disease study

Amgen reported positive topline Phase 3 results for a subcutaneous on-body injector version of TEPEZZA in adults with moderate-to-severe active thyroid eye disease. The primary endpoint of proptosis response at week 24 was met, with 76.7% of patients responding versus 19.6% on placebo. A working subcutaneous form could widen TEPEZZA's patient base beyond the current IV infusion.

• Proptosis response at week 24: 76.7% on subcutaneous TEPEZZA vs 19.6% on placebo (p<0.0001)
• Mean proptosis reduction -3.17 mm vs -0.80 mm on placebo (p<0.0001)
• On-body injector dosed every two weeks for 12 injections
• Result is a topline Phase 3 readout from the placebo-controlled period