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Monday, September 9, 2019

Horizon Therapeutics’ Teprotumumab nabs accelerated review status

The FDA grants Priority Review Designation to Horizon Therapeutics’ (NASDAQ:HZNP) BLA for teprotumumab, an investigational medicine for the treatment of active thyroid eye disease (TED).
PDUFA action date is March 8, 2020.
Priority Review shortens the review clock to six months from the standard 10 months.
If approved, teprotumumab would be the first FDA-approved medicine for the treatment of active TED.

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