FDA expert panel unanimously recommends approval for Horizon Therapeutics eye drug
An FDA advisory committee noted with concern a small safety database but unanimously endorsed a Horizon Therapeutics drug for a rare eye autoimmune disease that can blind patients: teprotumumab for thyroid eye disease (TED).
“It was a pretty easy vote,” said Erica Brittain, an NIH biostatistician and one of the 12 panelists on FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee.
After listening to testimony from patients and advocates, the advisers debated the drug’s label and whether there was enough data to properly understand the drug’s adverse effects, but rarely showed the kind of alarm that would lead to a ‘no’ vote. Horizon submitted a Phase III trial showing that the drug could dramatically lower proptosis, or bulging of the eye, by at least 2 mm in 89.2% of patients, but between the Phase III and the Phase II there were less than 90 patients actually treated with a profusion.
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