![]() Approximately 60 adult participants who meet the trial eligibility criteria will be randomized in a 2:1 ratio to receive an infusion of either Tepezza or placebo, 10 mg/kg for the first infusion and 20 mg/kg for the remaining seven infusions, once every 3 weeks, for a total of eight infusions. Participants cannot have had prior orbital irradiation, orbital decompression or strabismus surgery. At the time of the initial screening, all participants must be at least 18 years of age and have had an initial diagnosis of TED for at least 3 years and less than 8 years. This randomized, double-masked, placebo-controlled, parallel-group, multicenter trial will evaluate the efficacy, safety and tolerability of Tepezza compared to placebo in treating patients with chronic TED. This trial will help us understand these observations in a controlled clinical setting.” “It is common for patients who are in the chronic phase of the disease to continue having debilitating symptoms, like eye pain and bulging, that interfere with daily living and require treatment,” Raymond Douglas, MD, PhD, trial investigator and director of the Orbital and Thyroid Eye Disease Program, Cedars-Sinai Medical Center, said in a company news release. “In a number of published case reports and analyses, Tepezza improved Thyroid Eye Disease symptoms, including eye bulging, when administered in the chronic phase. 1,2 The disease then enters a chronic phase where inflammation is no longer present or has markedly diminished, but significant signs and symptoms may remain. TED begins with an acute (active) phase where inflammatory signs and symptoms, such as eye pain, swelling, proptosis (eye bulging) and diplopia (double vision), progress over time. Tepezza is the first and only medicine approved by the FDA for the treatment of TED-a serious, progressive and potentially vision-threatening rare autoimmune disease. The study will “evaluate objective biomarker and clinical endpoints to inform potential subsequent larger and longer duration clinical trials”, according to Horizon.Horizon Therapeutics announced that the first patient has been enrolled in a phase 4 clinical trial evaluating the efficacy and safety of Tepezza for the treatment of chronic (inactive) Thyroid Eye Disease (TED). Horizon plans to begin its pursuit of those opportunities by initiating an exploratory clinical trial in the coming months. ![]() “We believe teprotumumab may impact underlying mechanisms of fibrosis and could demonstrate utility beyond thyroid eye disease, including diffuse cutaneous scleroderma, a rare autoimmune disease with central characteristics of inflammation and fibrosis,” Lin said. Shao-Lee Lin, chief scientific officer at Horizon, set out the opportunity in the statement regarding the reset sales targets. There is scope to further grow Tepezza sales by moving into new indications. Horizon raised its revenue expectations for Krystexxa (pegloticase injection), a gout therapy that is already on the market, by the same amount. In light of the phase 3 data and further assessments of the TED market, Horizon increased its peak sales forecast for Tepezza from $750m (€677m) to $1bn. Horizon reset its expectations for the drug shortly before the FDA decision. Having secured the FDA approval, Horizon will now turn its attention to making a commercial success of Tepezza. ![]() Horizon looked to be on track to win approval for Tepezza last month when the FDA's Dermatologic and Ophthalmic Drugs Advisory Committee voted 12-0 in favour of the therapeutic when asked if its benefits outweigh its risks. More than half of patients who received Tepezza across the trials experienced the complete resolution of their double vision, as compared to one quarter of the placebo cohort. The trials also generated evidence that Tepezza improves double vision. Horizon demonstrated the potential for Tepezza to help these patients in phase 2 and 3 clinical trials that linked the monoclonal antibody to statistically significant reductions in eye bulging. ![]() Tepezza is the first medicine approved in the rare autoimmune disease, which can cause eye bulging, facial disfigurement and vision loss. The speed of the decision reflects the unmet need in TED. Yet, the agency reached a decision well ahead of that target, giving Horizon the green light to sell the insulin-like growth factor type 1 receptor inhibitor on Tuesday. The US Food and Drug Administration (FDA) was due to deliver a verdict on Tepezza (teprotumumab-trbw) on 8 March. Horizon Therapeutics has won a speedy approval for its thyroid eye disease (TED) treatment Tepezza in the US.
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