Amgen disclosed that its Phase 3 study of the subcutaneous formulation of TEPEZUMA (teprotumumab‑trbw) achieved a 77 % proptosis response rate, with a mean reduction of 3.17 mm in proptosis at week 24. The placebo group achieved a 19.6 % response rate, underscoring the drug’s robust efficacy when delivered by a subcutaneous on‑body injector.
The trial demonstrates that the subcutaneous route delivers the same level of clinical benefit as the intravenous formulation that earned FDA approval in 2020. By enabling self‑administration or clinic‑based injections, the new formulation could lower barriers to treatment, increase patient adherence, and broaden the patient population that can access TEPEZUMA.
Amgen’s TEPEZUMA has generated $1.9 billion in sales in 2024 and $457 million in Q4 2025, a 1 % year‑over‑year decline despite 11 % volume growth. The subcutaneous option is positioned to reverse that trend by expanding market penetration and potentially accelerating revenue growth, especially as the global thyroid eye disease market is projected to grow substantially.
Jay Bradner, M.D., Amgen’s executive vice president of research and development, said, “These results extend and support the best‑in‑class efficacy of TEPEZUMA for people living with Thyroid Eye Disease, now with subcutaneous administration delivering IV‑level efficacy. 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.”
The subcutaneous formulation aligns with Amgen’s broader rare‑disease strategy, reinforcing its leadership in a niche but growing market. By offering a more convenient delivery method, Amgen can defend its market share against emerging competitors and potentially unlock new patient segments, thereby supporting long‑term revenue growth and reinforcing the company’s rare‑disease portfolio.
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