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Friday, December 13, 2019

FDA advisory committee backs Horizon’s teprotumumab

The FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee voted 12-0 that the benefits of Horizon Therapeutics’ (NASDAQ:HZNP) teprotumumab outweigh the risks for the treatment of thyroid eye disease (TED).
The FDA’s action date is March 8, 2020.
Teprotumumab is a fully human monoclonal antibody that binds to (inhibits) a protein called insulin-like growth factor 1 receptor (IGF-1R). TED is a rare autoimmune disorder in which IGF-1R is overexpressed in the eye.

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