FDA supports Horizon's all-humanized monoclonal antibody teprotumumab for treatment of thyroid eye disease
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Last Update: 2020-06-07
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Source: Internet
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Author: User
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's(http:// announced inthat the u.SFDA(http://theof Theof Skin and EyeDrug(http:// advisory(http://Committee (DODAC) to support the company's all-humanized monoclonal monoclonal antibody teprotumab for the treatment of thyroid eye disease (TED)Teprotumumab is a fully humanized monoclonal antibody of insulin-like growth factor 1 receptor (IGF-1R)The signal path of IGF-1R mediateisist is blocked by binding to IGF-1R Teprotumumab has been granted fda-awarded ground-breaking therapeutic sins, orphan drug eligibility, fast-track eligibility, and priority review qualifications The effectiveness and safety of Teprotumab's treatment of TED is supported by a wealth of clinical evidence THE BLA SUBMISSION IS BASED ON THE POSITIVE RESULTS OF THE
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OF THE VALIDATED PHASE 3 CLINICAL
TRIAL CALLED OPTIC, AS WELL AS THE RESULTS OF A PHASE 2 CLINICAL TRIAL THE OPTIC STUDY FOUND THAT 82.9 PERCENT OF PATIENTS TREATED WITH TEPROTUMUMAB HAD SIGNIFICANT LYNOUT EYE PROSISINATION WITHIN SIX MONTHS OF TREATMENT, COMPARED WITH 9.5 PERCENT IN THE PLACEBO GROUP Teprotumumab reaches all secondary endpoints, including reduced re-vision, improved quality of life, etc
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