Approved more than a month in advance! FDA today approved the first treatment for thyroid ophthalmopathy

Today, horizon therapeutics announced that the U.S FDA has approved its innovative therapy tepezza (tepromumab trbw) for the treatment of thyroid eye disease (TED) It is worth mentioning that this is the first approved treatment for this rare eye disease! Moreover, this approval is more than a month ahead of the expected date! Ted is a rare and progressive autoimmune disease that threatens vision The symptoms of patients include exophthalmos, diplopia, blurred vision, pain and facial deformity, which may seriously affect the quality of life of patients This is a unique disease that often occurs in hyperthyroidism patients The cause is that autoantibodies activate the signal complex mediated by IGF-1R in orbital cells The disease is divided into several different stages, of which the active stage lasts for about 2-3 years, lacking effective treatment Only after the disease has entered a stable period can it be treated by ophthalmic surgery For etiology, teprotumumab developed by horizon therapeutics can block the signal pathway mediated by IGF-1R In two clinical trials, the treatment showed good results - after 24 weeks of treatment, 82.9% of the patients who received teprotumumab had a significant improvement in exophthalmos, compared with 9.5% in the placebo group At the same time, teprotumumab reached all secondary end points, including reducing diplopia and improving quality of life Based on these results, FDA has awarded it breakthrough therapy certification, orphan drug qualification, fast track qualification, and priority review qualification The original response date for the drug was March 8 Today's approval is more than 1 month earlier than expected! Action mechanism of teprotumumab (picture source: reference [3]) reference material: [1] FDA approves first treatment for thyroid eye disease, Retrieved January 21, 2020, from https:// [2] FDA Approves TEPEZZA (teprotumumab-trbw) for the Treatment of Thyroid Eye Disease (TED), Retrieved January 21, 2020, from https:// [3] Teprotumumab Overview Retrieved Feb 28, 2019, from https:// Note: the original text has been deleted A kind of