Horizon Therapeutics PLC (NASDAQ:HZNP) disclosed that the FDA Advisory Committee has voted unanimously to support use of teprotumumab for Thyroid Eye Disease (TED)
TED is a rare, serious, progressive and vision-threatening autoimmune disease, and is associated with proptosis (eye bulging), diplopia (double vision), blurred vision, pain and facial disfigurement that can significantly impact patients’ quality of life.
If approved, teprotumumab would be the first FDA-approved medicine for TED. Teprotumumab, flagship of the Dublin-based HZNP, is an investigational medicine and its safety and efficacy have not been established.
Said CEO Timothy Walbert, “Our comprehensive set of data presented today on teprotumumab’s efficacy and safety is a testament to the extraordinary efforts of the physicians who partnered with us on the clinical development program, the TED patients who enrolled in our studies, and Horizon’s research and development team.
“We believe that teprotumumab has the potential to address a significant unmet need for these patients and we look forward to working with the FDA as it completes its review of our application.”
The FDA is currently evaluating a Biologics License Application for teprotumumab for the treatment of TED. Teprotumumab is one of less than five medicines ever to receive Priority Review, Orphan Drug, Fast Track and Breakthrough Therapy designations from the FDA.
The Prescription Drug User Fee Act action date is March 8, 2020. The FDA will consider Friday’s vote as it reviews the BLA, although it is not obligated to follow the Committee’s recommendation.
Shares in HZNP gained $1.37, or 4.2%, to $34.21