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Tepezza receives orphan drug designation in Korea

By Eo, Yun-Ho | translator Alice Kang

24.08.06 06:27:42

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Approved in the U.S. in 2020, company applies for approval in Europe and Japan

The only targeted biological inhibitor of insulin-like growth factor-1 receptor (IGF-1R)


Tepezza (teprotumumab), a targeted treatment for thyroid eye disease (TED), has been designated as an orphan drug in Korea.

The Ministry of Food and Drug Safety (MFDS) recently announced the designation through an orphan drug designation notification.

Specifically, Tepezza is indicated for the treatment of adult patients with moderate-to-severe thyroid ophthalmopathy.

Tepezza is an insulin-like growth factor-1 receptor inhibitor class monoclonal antibody that is administered intravenously every 3 weeks (8 injections in total). The drug was first approved by the U.S. FDA after receiving a fast-track designation in January 2020 but has not yet been commercialized in Kor

Eo, Yun-Ho(unkindfish@dailypharm.com)
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