Horizon Therapeutics announced that there will be short-term disruption in the production of Tepezza® (teprotumumab-trbw) due to government-mandated coronavirus disease 2019 (COVID-19) vaccine production orders related to Operation Warp Speed.
As both the vaccine and Tepezza are being manufactured at Catalent, the government has prioritized the manufacturing of the vaccine thereby resulting in cancellation of previously contracted Tepezza orders. According to Horizon Therapeutics, the Tepezza supply shortage is expected to begin at the end of December and could last through the first quarter of 2021.
Tepezza, a fully human monoclonal antibody, is approved for the treatment of thyroid eye disease. The drug is administered as an intravenous infusion.
As a result of the supply disruption, Horizon is delaying new patients starting on Tepezza. The Company will be reaching out to current patients and health care providers with additional information regarding supply.
“We understand the impact that the Tepezza supply disruption will have on patients with TED and physicians who treat them,” said Tim Walbert, chairman, president and chief executive officer, Horizon. “Our job is to support these patients and physicians and we will continue to work closely with the FDA and Operation Warp Speed to limit the length of this disruption and accelerate the availability of Tepezza drug product supply.”
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Horizon Therapeutics plc announces short-Term TEPEZZA® (teprotumumab-trbw) supply disruption due to government-mandated (Operation Warp Speed) COVID-19 vaccine production. [press release]. December 17, 2020.