The Ministery of Food and Drug Safety said on the 30th it approved the rare disease drug "Tepezza injection" (teprotumumab) for treating adults with severe thyroid eye disease.
Thyroid eye disease is an autoimmune disorder in which autoantibodies attack the muscles and fat tissue around the eyes, causing abnormal reactions.
This is the first domestic approval for a thyroid eye disease treatment. Designated as No. 42 under the Ministery of Food and Drug Safety's Global Innovative product Fast-Track (GIFT) review program, it underwent expedited review.
Tepezza works by blocking insulin-like growth factor 1 receptor (IGF-1R) signaling to regulate inflammation and autoimmune pathophysiology. Developed by Horizon Therapeutics and approved by the U.S. Food and Drug Administration (FDA) in 2020, the product became Amgen's after Amgen acquired Horizon for about $27.8 billion in 2023.
A Ministery of Food and Drug Safety official said it is expected "to provide patients with a non-surgical treatment option."