Rare eye disease first treatment teprotumumab receives full vote from FDA advisory board

TED is a rare performing severe autoimmune disease that threatens visionSymptoms include eye protrusion, re-vision, blurred vision, pain and facial deformities, which can seriously affect the patient's quality of lifeAlthough TED often occurs in people with hyperthyroidism or Grave's disease, it is a unique disease caused by autoantibodies activating the insulin-like growth factor 1 receptor 1 receptor (IGF-1R)-mediated signal complex in the cells in the eye socketTED will be active for about two to three years before entering a stabilization periodActive period TED lacks effective treatmentUntil the stabilization period, TED can accept eye socket, eye muscle and other eye surgery to restore vision or appearanceTeprotumumab 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-1RIt has been granted by the FDA for breakthrough therapy, orphan drug eligibility, fast-track eligibility, and priority reviewthe mechanism of the role of Teprotumumab (Photo: Resources,The effectiveness and safety of Teprotumab's treatment of TED is supported by a wealth of clinical evidenceTHE BLA SUBMISSION IS BASED ON POSITIVE RESULTS FROM A VALIDATED PHASE 3 CLINICAL TRIAL CALLED OPTIC, AS WELL AS THE RESULTS OF A PHASE 2 CLINICAL TRIALTHE OPTIC STUDY FOUND THAT 82.9 PERCENT OF PATIENTS TREATED WITH TEPROTUMUMAB
HAD SIGNIFICANT IMPROVEMENTS IN EYE PRONOUNS DURING THE SIX-MONTH PERIOD, COMPARED WITH 9.5 PERCENT OF
IN THE PLACEBO GROUPAt the same time, teprotumumab reaches all secondary endpoints, including reduced re-vision and improved quality of life"Today's full-vote support marks an important step toward the FDA-approved first treatment for TED patients, an autoimmune disease that threatens vision," said Timothy Walbert, President and CEO of HorizonReferences:Retrieved December 13, 2019, from https:// Teprotumumab Overview Origind Feb 28, 2019, from https:// original title: Courier FDA Advisory Committee full vote to support! First treatment for rare eye disease expected