Benzinga | Mar 30, 2021 07:33AM EDT

Horizon Therapeutics PLC To Resupply Market With TEPEZZA For The Treatment Of Thyroid Eye Disease Beginning in April

Horizon Therapeutics plc (NASDAQ:HZNP) today announced that the U.S. Food and Drug Administration (FDA) has approved a prior approval supplement (PAS) to the previously approved Biologics Licensing Application (BLA) giving Horizon authorization to manufacture more TEPEZZA drug product resulting in an increased number of vials with each manufacturing slot. The company plans to resupply the market beginning in April, which will end the supply disruption that began in December 2020 following U.S. government orders prioritizing the manufacturing of a COVID-19 vaccine.

"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. We understand the ongoing need for vaccine production and hope that the Biden Administration continues to prioritize all patients who need access to medically necessary treatments."