Biologics

Positive Phase 3 Date for Subcutaneous Tepezza: Amgen

Amgen says it has achieved positive topline results from a Phase 3 trial evaluating a subcutaneous version of its thyroid eye disease drug Tepezza (teprotumumab-trbw), potentially paving the way for a more convenient alternative to the currently approved intravenous formulation.

The study met its primary endpoint, with patients receiving Tepezza via an on-body injector achieving a 77% proptosis response rate at 24 weeks, compared with 19.6% for placebo. The reduction in eye bulging — a hallmark symptom of the disease — was also significantly greater in the treatment arm, with a mean decrease of 3.17 mm versus 0.80 mm for placebo.

The results suggest that subcutaneous administration could deliver efficacy comparable to intravenous Tepezza, which has been on the market since 2020 and is the only approved treatment for Thyroid Eye Disease, a rare and potentially vision-threatening autoimmune disorder, according to the company.

In addition to the primary endpoint, the trial showed statistically significant improvements across multiple secondary measures, including overall response rates, disease activity scores, and outcomes related to double vision and quality of life. A visual functioning measure trended in favor of the drug but did not reach statistical significance.

Safety findings were generally consistent with the known profile of intravenous Tepezza. The most common adverse events included muscle spasms, tinnitus, weight loss, nausea and diarrhea. Mild-to-moderate injection site reactions were reported with the subcutaneous formulation but did not lead to treatment discontinuation, the company says.

Amgen says full data from the study will be presented at an upcoming medical meeting. The company also notes it has completed a separate post-marketing study of intravenous Tepezza required by FDA, with results to be submitted to regulators.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome