Horizon Therapeutics announced that the 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.”
Information for Patients
TED patients who have been affected by the Tepezza supply disruption should talk with their doctor about their plan for starting or resuming treatment and share the plan with their infusion center. Patients can contact their infusion center directly to schedule their infusions or call their Horizon Patient Access Liaison (PAL) if they have questions about the process of starting or resuming treatment.
To enroll in Horizon Patient Services, call 1‐833‐583‐7399 Monday to Friday, 8 a.m. through 8 p.m. ET. Additional information for patients is available on Horizon’s website.
Physicians with questions should call or email Horizon Medical Information at 1-866-479-6742 or [email protected].