Amgen announces new positive topline phase 3 results for subcutaneous Tepezza

Amgen has recently announced their new positive topline results from a Phase 3 trial of TEPEZZA administered by subcutaneous injection via an on-body injector in participants with moderate-to-severe active Thyroid Eye Disease. TEPEZZA provides comparable efficacy to, and builds upon the success of, intravenous TEPEZZA, the first and only medicine approved for the treatment of TED, which has now treated more than 25,000 patients worldwide.

Note that the Phase 3 TEPEZZA OBI trial met its primary endpoint in moderate-to-severe active TED, showing a statistically significant and clinically meaningful 77% proptosis response rate during the 24-week placebo-controlled period. The mean proptosis reduction, a key secondary endpoint, was -3.17 mm at week 24.

“These results extend and support the best-in-class efficacy of TEPEZZA for people living with Thyroid Eye Disease, now with subcutaneous administration delivering IV-level efficacy,” said Jay Bradner, M.D., executive vice president of Research and Development at Amgen. “With a well-understood mechanism and established impact in the clinic, we can evolve how the medicine is delivered to potentially reach even more patients through a more convenient subcutaneous option.”

In addition, the trial also showed statistically significant and clinically meaningful improvements across the following additional secondary endpoints: overall responder rate; percentage of patients achieving a Clinical Activity Score of 0 or 1; change in diplopia as ordinal response categories; diplopia response rate; complete diplopia responder rate; and mean change from baseline in week 24 in the Graves’ Ophthalmopathy Quality of Life appearance subscale.

Note that the overall safety results were generally consistent with the known safety profile of TEPEZZA IV. Mild-to-moderate injection site reactions were observed with subcutaneous administration in some patients, which did not result in treatment interruption or discontinuation.

“Thyroid Eye Disease can be a profoundly debilitating condition, affecting not only vision but also daily functioning with symptoms like double vision and eye bulging,” said Dr. Madhura A. Tamhankar, M.D., professor of ophthalmology and neurology at the Scheie Eye Institute, University of Pennsylvania. “Expanding administration options through subcutaneous delivery opens the possibility of a more accessible experience for patients with Thyroid Eye Disease and is critical to serving diverse patient needs. The potential to achieve comparable efficacy to IV makes this advancement compelling.”

---

---

Related Topics and Keywords

Amgen, subcutaneous Tepezza, tepezza