Horizon announces results from Tepezza trial in patients with CAS, TED

Horizon Therapeutics announced positive and statistically significant topline results from its randomized, double-masked, placebo-controlled Phase 4 clinical trial evaluating TEPEZZA for the treatment of adults with chronic TED and low CAS, which is a measure of disease activity. The totality of clinical trial data continues to strongly support the efficacy of TEPEZZA across a broad spectrum of TED patients regardless of disease activity or duration, with a well-established safety profile. TEPEZZA is the first and only medicine approved by the U.S. Food and Drug Administration for the treatment of TED – a serious, progressive, debilitating and potentially vision-threatening rare autoimmune disease. "We are thrilled with the topline results, which reinforce that TEPEZZA significantly reduces proptosis in people living with Thyroid Eye Disease, regardless of their disease activity or duration, and underscores what we learned from our initial trials and what we have seen through more than three years of real-world use of TEPEZZA," said Elizabeth H.Z. Thompson, Ph.D., executive vice president, research and development, Horizon. "With TEPEZZA, physicians have a medicine that can be used in a broad range of Thyroid Eye Disease patients, including those with long-duration disease of more than 5 years on average in this trial, which is important because we know the negative impact of the disease can be significant across all types of Thyroid Eye Disease patients. We look forward to discussing these data with the FDA to determine our next steps."