Proptosis is the main cause of morbidity in TED. All secondary endpoints were also met and the safety profile was consistent with the Phase II study of teprotumumab in TED. On 10 July 2019, Horizon submitted a Biologics License Application (BLA) to the FDA for teprotumumab for the treatment of active thyroid eye disease (TED). Horizon requested priority review for the application - if so granted (FDA has a 60-day review period to decide) it would result in a max. 6 month review process. History
Teprotumumab-trbw was approved for use in the United States in January 2020, for the treatment of adults with thyroid eye disease.Teprotumumab was first investigated for the treatment of solid and hematologic tumors, including breast cancer, Hodgkins and non-Hodgkins lymphoma, non-small cell lung cancer and sarcoma. Although results of Phase I and early Phase II trials showed promise, research for these indications were discontinued in 2009, by Roche. Phase II trials still in progress were allowed to complete, as the development was halted due to business prioritization rather than safety concerns. Teprotumumab was subsequently licensed to River Vision Development Corporation in 2012, for research in the treatment of ophthalmic conditions. Horizon Pharma (now Horizon Therapeutics, from hereon Horizon) acquired RVDC in 2017, and will continue clinical trials. It is in Phase III trials for Graves ophthalmopathy (also known as thyroid eye disease (TED)) and Phase I for diabetic macular edema.
It has been recognized as a treatment-responsive syndrome congenial to anti-epileptic drugs. Semantic amnesia affects semantic memory and primarily expresses itself in the form of problems with language use and acquisition. Semantic amnesia can lead to dementia. Pseudodementia (otherwise known as depression-related cognitive dysfunction) is a condition where mental cognition can be temporarily decreased. The term pseudodementia is applied to the range of functional psychiatric conditions such as depression and schizophrenia, that may mimic organic dementia, but are essentially reversible on treatment. Pseudodementia typically involves three cognitive components: memory issues, deficits in executive functioning, and deficits in speech and language. Specific cognitive symptoms might include trouble recalling words or remembering things in general, decreased attentional control and concentration, difficulty completing tasks or making decisions, decreased speed and fluency of speech, and impaired processing speed. People with pseudodementia are typically very distressed about the cognitive impairment they experience. With in this condition, there are two specific treatments that have been found to be effective for the treatment of depression, and these treatments may also be beneficial in the treatment of pseudodementia. Cognitive behavioral therapy (CBT) involves exploring and changing thought patterns and behaviors in order to improve ones mood. Interpersonal therapy focuses on the exploration of an individuals relationships and identifying any ways in which they may be contributing to feelings of depression. Treatment
Many forms of amnesia fix themselves without being treated. However, there are a few ways to cope with memory loss if treatment is needed.