The FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee voted unanimously to support Horizon Pharma’s teprotumumab infusion to treat active thyroid eye disease (TED).
If approved, the human monoclonal antibody will be the first pharmacotherapy indicated for the treatment of TED.
The 12-member panel agreed that teprotumumab’s potential benefits outweighed the risks, but said the FDA should require labeling to state the risks of inflammatory bowel disease and hearing loss. “The prescribing physician needs to have a heightened awareness” of the hearing loss, said James Chodosh, a professor of ophthalmology at Harvard Medical School.
The committee also suggested that patients getting infusions should monitor their glucose levels, as the trial showed increased glucose levels. Cecilia Lo Wang, professor of medicine at the University of Colorado, recommended baseline testing of patients for glucose and hemoglobin A1C.