FDA Committee Unanimously Recommends Approval of Teprotumumab for Thyroid Eye Disease | oneGRAVESvoice

welcome to oneGRAVESvoice

- a positively charged Graves' disease and thyroid eye disease community.
  • join today!

FDA Committee Unanimously Recommends Approval of Teprotumumab for Thyroid Eye Disease


The Dermatologic and Ophthalmic Drugs Advisory Committee of the FDA voted 12-0 Friday in favor of recommending approval of a biologics license application for teprotumumab, an experimental human monoclonal antibody shown to dramatically reduce the most debilitating symptoms of Graves’ orbitopathy.

Committee members expressed concern before casting votes about the small patient population studied — fewer than 90 adults treated with infusions of teprotumumab (Horizon Therapeutics) have been enrolled in controlled clinical trials — and several adverse events reported, among them hearing loss, muscle spasms, hyperglycemia and infections. In briefing materials, the FDA noted the population was considerably smaller than the common safety database of greater than 300 patients treated with a course of therapy. However, committee members ultimately agreed that the benefits of the drug outweighed any potential risks.

FDA Committee Unanimously Recommends Approval Of Teprotumumab For Thyroid Eye Disease
Font Resize

To improve your experience on this site, we use cookies. This includes cookies essential for the basic functioning of our website, cookies for analytics purposes, and cookies enabling us to personalize site content. By clicking on 'Accept' or any content on this site, you agree that cookies can be placed. You may adjust your browser's cookie settings to suit your preferences.
More information

The cookie settings on this website are set to "allow cookies" to give you the best browsing experience possible. If you continue to use this website without changing your cookie settings or you click "Accept" below then you are consenting to this.

Close