As a result of direct patient advocacy to the U.S. Food and Drug Administration (FDA) through Prevent Blindness, patients will be able to resume their treatments for thyroid eye disease beginning in April 2021. For months, patients who live with thyroid eye disease (TED) have been unable to access the only available, FDA-approved treatment for TED—teprotumumab (TEPEZZA). A mandatory, federal COVID-19 vaccine production order that was implemented in December 2020 incapacitated manufacturer’s ability to produce this necessary treatment alongside increase vaccine production. As a result, patients who rely on the 24-week course of TEPEZZA to treat their TED had to stop their courses of treatment as the drug became unavailable. Consequences of disruption in treatment can cause a regression of the disease, which causes proptosis that not only causes discomfort and pain but can alter a person’s physical appearance, double vision that makes it difficult to engage in activities, and the emotional, mental, and financial ramifications related to treatment disruption and uncertainty of when the treatment will be available again.
Since the start of the drug shortage, Prevent Blindness has been urging the FDA to exercise authorities granted under the CARES Act to alleviate drug shortages and allow production of TEPEZZA to move forward alongside necessary, increased COVID-19 vaccine production. Prevent Blindness applauds the FDA’s decision to allow production of TEPEZZA to resume so that patients living with TED can access medically-necessary, sight-saving care.
For additional information: FAQ’s for Patients; FDA Authority to Help Prevent Drug Shortages for Patients with Eye Diseases & Other Conditions