FDA approves first treatment for thyroid eye disease

On Tuesday, the US Food and Drug Administration approved Tepezza (teprotumumab-trbw) for the treatment of adults with thyroid eye disease (TED), a rare condition where the muscles and fatty tissues behind the eye become inflamed, causing the eyes to be pushed forward and bulge outwards (proptosis). This represents the first drug approved for the treatment of thyroid eye disease.

The FDA approval of Tepezza comes ahead of the Prescription Drug User Fee Act (PDUFA) goal date of March 8, 2020. The medicine received Priority Review, Orphan Drug, Fast Track and Breakthrough Therapy designations from the FDA, says the drug’s developer, Ireland-incorporated Horizon Therapeutics (Nasdaq: HZNP), whose shares were up almost 2% at $39.00 pre-market this morning.

Tepezza is expected to be available in the USA in the coming weeks, the company said. Analysts forecast that US revenues for the therapy could reach up to $700 million at peak.