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)
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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