Horizon Therapeutics has submitted a biologics license application to the FDA for its investigational thyroid eye disease treatment candidate teprotumumab, according to a press release.
The application includes results from the OPTIC confirmatory phase 3 clinical trial, which compared teprotumumab infusion with placebo and measured improvement in proptosis as the primary endpoint. Proptosis improved 2 mm or more in 82.9% of treated patients compared with 9.5% in the placebo group.
“There is a major unmet need for an effective therapy for active thyroid eye disease, a painful and
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