Horizon Teprotumumab's US Advisory Cmte. Likely To Focus On Labeling, Not Approval, Questions

FDA seems poised to approve the drug for the orphan eye disease called TED, but remains concerned about labeling for some adverse events.

Close-up of blue eye. High Technologies in the futuristic. : cataract
Teprotumumab is proposed to treat a rare eye condition called active throid eye disease (TED). • Source: Shutterstock

Several seemingly minor safety issues could complicate the labeling discussions for Horizon Therapeutics PLC's teprotumumab, proposed for active thyroid eye disease (TED), a rare condition.

US Food and Drug Administration assessors did not indicate any of the adverse events mentioned could prevent or delay approval....

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