Food and Drug Administration (FDA) for the treatment of TED regardless of disease activity or duration. TEPEZZA is the first and only medicine approved by the U.S. These findings, along with new subgroup data from the TEPEZZA Phase 4 clinical trial in patients with long disease duration and low Clinical Activity Score (CAS) and an analysis of the impact of TED on QOL, were shared at the 92 nd Annual Meeting of the American Thyroid Association ( ATA 2023), Sept. Horizon Therapeutics plc HZNP today announced new data showing that disrupting the recommended TEPEZZA treatment regimen by lengthening the amount of time between infusions can increase the need for a second course of treatment. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.- Additional data presented at ATA 2023 include a subgroup analysis from the TEPEZZA Phase 4 clinical trial and insights on the impact of TED on quality of life (QOL). Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The FDA granted the approval of Tepezza to Horizon Therapeutics Ireland DAC. Development of this product was also in part supported by the FDA Orphan Products Grants Program, which provides grants for clinical studies on safety and efficacy of products for use in rare diseases or conditions. Additionally, Tepezza received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases or conditions. The FDA granted this application Priority Review, in addition to Fast Track and Breakthrough Therapy Designation. Tepezza should not be used if pregnant, and women of child-bearing potential should have their pregnancy status verified prior to beginning treatment and should be counseled on pregnancy prevention during treatment and for 6 months following the last dose of Tepezza. The most common adverse reactions observed in patients treated with Tepezza are muscle spasm, nausea, alopecia (hair loss), diarrhea, fatigue, hyperglycemia (high blood sugar), hearing loss, dry skin, dysgeusia (altered sense of taste) and headache. Of the patients who were administered Tepezza, 71% in Study 1 and 83% in Study 2 demonstrated a greater than 2 millimeter reduction in proptosis (eye protrusion) as compared to 20% and 10% of subjects who received placebo, respectively. Tepezza was approved based on the results of two studies (Study 1 and 2) consisting of a total of 170 patients with active thyroid eye disease who were randomized to either receive Tepezza or a placebo. For example, the troubling ocular symptoms can lead to the progressive inability of people with thyroid eye disease to perform important daily activities, such as driving or working. Although this condition impacts relatively few individuals, thyroid eye disease can be incapacitating. This disease impacts a relatively small number of Americans, with more women than men affected. Thyroid eye disease is associated with the outward bulging of the eye that can cause a variety of symptoms such as eye pain, double vision, light sensitivity or difficulty closing the eye. This approval represents important progress in the approval of effective treatments for rare diseases, such as thyroid eye disease.” “Additionally, thyroid eye disease is a rare disease that impacts a small percentage of the population, and for a variety of reasons, treatments for rare diseases are often unavailable. This treatment has the potential to alter the course of the disease, potentially sparing patients from needing multiple invasive surgeries by providing an alternative, non surgical treatment option,” said Wiley Chambers, M.D., deputy director of the Division of Transplant and Ophthalmology Products in the FDA’s Center for Drug Evaluation and Research. Currently, there are very limited treatment options for this potentially debilitating disease. “Today’s approval marks an important milestone for the treatment of thyroid eye disease. Today’s approval represents the first drug approved for the treatment of thyroid eye disease. Food and Drug Administration (FDA) approved Tepezza (teprotumumab-trbw) for the treatment of adults with thyroid eye disease, a rare condition where the muscles and fatty tissues behind the eye become inflamed, causing the eyes to be pushed forward and bulge outwards (proptosis).
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