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 sight-threatening disease with no FDA-approved treatment options,” Timothy Walbert, chairman, president and CEO of Horizon said. “Our BLA submission is an important step toward our goal of making teprotumumab available as soon as possible for patients with this debilitating disease.”
Horizon has requested priority review of the application. Teprotumumab has breakthrough therapy, orphan drug and fast track designations from the FDA. A priority review could mean a 6-month review process.