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.

Endocrine Today has compiled a list of recent FDA news stories relating to endocrine practice. Drugs under consideration included those for thyroid eye disease, diabetes, hypertriglyceridemia, Prader-Willi syndrome and nonalcoholic steatohepatitis.

Endocrine Today has compiled a list of the top five news reports posted from the American Thyroid Association Annual Meeting, held from Oct. 30 to Nov. 3 in Chicago.

CHICAGO — In this video exclusive, Endocrine Today Editorial Board Member Stephanie L. Lee, MD, PhD, FACE, ECNU, professor of medicine and director of thyroid health in the section of endocrinology, diabetes and nutrition at Boston Medical Center, discusses four important studies presented at the American Thyroid Association Annual Meeting.

CHICAGO — Thyroid eye disease, a condition most commonly associated with Graves’ hypothyroidism, typically comes with a range of symptoms that can make everyday tasks challenging and quickly reduce quality of life. Within 18 months of a diagnosis of Graves’ disease, approximately 80% of patients will develop thyroid eye disease, with symptoms including proptosis, the main cause or morbidity, as well as eyelid retraction, strabismus and compressive optic neuropathy.

CHICAGO — Among adults with recent-onset thyroid eye disease, those who received the monoclonal human antibody teprotumumab experienced substantial symptom relief and reported quality of life gains compared with those assigned placebo, according to pooled data from a phase 2 and a phase 3 clinical trial of the drug presented at the American Thyroid Association annual meeting.

SAN FRANCISCO — Rather than thinking of ophthalmic Graves’ disease as one entity classified as “mild” or “moderate to severe,” William R. Nunery, MD, FACS, told colleagues at the American Society of Ophthalmic Plastic and Reconstructive Surgery meeting that thyroid eye disease should be considered as two separate subtypes.

The FDA on Monday granted priority review of the investigational medication teprotumumab for treatment of thyroid eye disease, also known as Graves’ orbitopathy according to a press release from Horizon Therapeutics.