Ireland-headquartered biotech Horizon Therapeutics (Nasdaq: HZNP) on Monday announced positive and statistically-significant top-line results from its randomized, double-masked, placebo-controlled Phase IV clinical trial evaluating Tepezza (teprotumumab-trbw) for the treatment of adults with chronic thyroid eye disease drug (TED) and low CAS, which is a measure of disease activity.
Tepezza is the first and only medicine approved by the US Food and Drug Administration (FDA) for the treatment of TED – a serious, progressive, debilitating and potentially vision-threatening rare autoimmune disease, noted Horizon, which is currently the subject of a $28 billion acquisition by Amgen (Nasdaq: AMGN) announced in December. Horizon is forecasting peak annual sales of more than $4 billion for the drug.
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