The U.S. Food and Drug Administration (FDA) has approved Tepezza (teprotumumab) for the treatment of Thyroid Eye Disease (TED), according to its manufacturer Horizon Therapeutics.
TED is a rare yet serious autoimmune disease that is characterized by eye bulging (proptosis), double vision (diplopia), blurry vision, along with pain, inflammation, and disfiguration of the face.
Tepezza targets and inhibits the insulin-like growth factor-1 receptor. It is administered to patients once every three weeks, with eight infusions.
President and CEO of Horizon Therapeutics Timothy Walbert said, “Today is a great day for people living with Thyroid Eye Disease, a rare, vision-threatening disease that previously had no FDA-approved treatment options.”
“The TED community has gone far too long without an FDA-approved therapy, and we are grateful to the people living with TED and physicians who partnered with us on the clinical development program that led to today’s approval of Tepezza,” he continued.
“This also marks the early approval of Horizon’s first Biologics License Application – a key step in our evolution to an innovation-focused biopharma company, developing new medicines for debilitating diseases with few or no treatment options,” added Walbert.
Director of the Orbital and Thyroid Eye Disease Program, Cedars-Sinai Medical Center, Dr. Raymond Douglas, said, “The FDA approval of Tepezza is momentous for the TED community and has the potential to change the treatment paradigm for TED – providing new hope for people who are living with this horrible, vision-threatening disease.”
“Today’s news brings forward a medicine for patients that targets the underlying biology of the disease and has been shown to significantly improve eye-bulging and double vision, which are the most debilitating aspects of the disease,” Dr. Douglas added.
President and CEO of Prevent Blindness Jeff Todd said, “Tepezza is a much-needed breakthrough for a community of people who have historically had to struggle in pain as their symptoms progress – risking permanent damage to their eyes and making it extremely difficult to go about their daily lives.”
“This approval is meaningful to our organization because we are committed to helping patients with vision impairment and those who are at significant risk,” he added.
The most common side effects of Tepezza include nausea, diarrhea, muscle spasm, alopecia, fatigue, hyperglycemia, taste and hearing impairment, headache, and dry skin.
Tepezza will be available in the United States in the coming weeks. It is expected that Horizon would make nearly $105 million in milestone payments in the first half of 2020 with the approval of Tepezza.