Horizon Therapeutics has been given the green light to manufacture Tepezza® (teprotumumab-trbw) after the Food and Drug Administration (FDA) approved a Prior Approval Supplement to the previously approved Biologics License Application. This allows the Company to produce more of the drug product and resupply the market beginning in April.
Tepezza, a fully human monoclonal antibody, is approved for the treatment of thyroid eye disease. The drug is administered as an intravenous infusion.
In December 2020, Horizon announced that there would be a short-term disruption in the production of Tepezza due to government-mandated COVID-19 vaccine production orders related to Operation Warp Speed. As both the vaccine and Tepezza were being manufactured at Catalent, the government had prioritized the manufacturing of the vaccine thereby resulting in cancellation of previously contracted Tepezza orders.
“We commend the efforts of the FDA and the Biden Administration to accelerate COVID-19 vaccine production while working together with our team so that people living with thyroid eye disease are able to resume or start treatment with Tepezza,” said Tim Walbert, chairman, president and chief executive officer, Horizon. “We are pleased that patients who have had to struggle with the debilitating effects of thyroid eye disease will soon have access again to Tepezza, the only FDA-approved medicine to treat this rare disease, and we appreciate their patience and understanding during this unfortunate disruption.”
Healthcare professionals with questions related to Tepezza can call Horizon Medical Information at 1-866-479-6742 or email at [email protected].
Horizon Therapeutics plc to resupply market with Tepezza® (teprotumumab-trbw) for the treatment of thyroid eye disease (TED) beginning in April. [press release]. Dublin, Ireland: Horizon Therapeutics plc; March 30, 2021.