Amgen has announced that a subcutaneous version of its blockbuster drug Tepezza—a treatment for thyroid eye disease (TED)—successfully met both primary and key secondary endpoints in a pivotal late-stage trial. These findings are expected to help Amgen defend its market dominance against emerging competitors.
Key technical details and results from the study include:
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New Delivery Method: Instead of time-consuming intravenous infusions, Tepezza OBI is administered via an on-body injector. Amgen noted that this newer version demonstrated “IV-like efficacy,” providing a more convenient alternative to the currently marketed infusion.
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Efficacy Metrics: Over the 24-week study period, 77% of patients treated with Tepezza OBI responded to treatment (achieving a meaningful reduction in eye bulging, or proptosis), compared to 20% in the placebo group. The mean reduction in proptosis was 3.17 mm, significantly higher than the 0.80 mm decline observed in the control group.
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Strategic Rationale: Tepezza is the first and only approved therapy for TED, generating nearly $2 billion in annual sales. However, growth has stagnated recently due to limited access to infusion centers. The transition to a subcutaneous option is anticipated to enable at-home administration, reaching more patients and revitalizing the franchise.
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Competitive Landscape: Amgen is in direct competition with Viridian Therapeutics, which is developing its own subcutaneous injection using an autoinjector. While some analysts suggest that Amgen’s on-body device might be less optimal than a simple autoinjector, Tepezza’s robust clinical data has already put significant pressure on its rivals’ market standing.
Full safety data, particularly regarding hearing-related side effects associated with Tepezza, will be disclosed at an upcoming medical meeting as the company prepares its regulatory submissions.
Source: https://www-biopharmadive-com.translate.goog/news/amgen-subcutaneous-tepezza-thyroid-eye-disease-results/816708/?_x_tr_sl=en&_x_tr_tl=vi&_x_tr_hl=vi&_x_tr_pto=tc