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Teprotumumab (Tepezza): from the discovery and development of medicines to USFDA approval for active thyroid eye
Faraat Ali1, Anushma Chorsiya2, Varisha Anjum3
1Laboratory Services, Botswana Medicines Regulatory Authority (BoMRA), Plot 112, International Finance Park, Gaborone, Botswana. FRHTL6@gmail.com.
Abstract:
Teprotumumab (TPT) is a type I insulin-like growth factor receptor inhibitor, marketed as Tepezza; recently USFDA approved it for the treatment of thyroid eye disease (thyroid-associated ophthalmopathy (TAO), Graves ophthalmopathy/orbitopathy) in the USA. It is a monoclonal antibody although it was initially developed in collaboration with Genmab and Roche for the treatment of the tumour, but later it was investigated by River Vision Development Corporation and Horizon Therapeutics for its ophthalmic use. The drug has been designated as an orphan drug, breakthrough designation and fast-track designation. This review summarizes the milestones in the research and development including ongoing, clinical trial of TPT till now, foremost to this primary approval for thyroid-associated ophthalmopathy (TAO).
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