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Horizon's Teprotumumab Breezes Through US FDA Adcom, But Safety Questions Remain

 
• By Derrick Gingery

Efficacy data were striking to committee members, but they want to ensure postmarketing plans gather adequate data to address safety questions.

FDA Advisory Committee Feature image
The Dermatologic and Ophthalmic Drugs Advisory Committee voted 12-0 that teprotumumab's benefits outweighed risks.

Horizon Therapeutics PLC's teprotumumab cruised to a favorable advisory committee recommendation for use in active thyroid eye disease (TED), with a recognition that some safety issues should be clarified after approval.

The US Food and Drug Administration's Dermatologic and Ophthalmic Drugs Advisory Committee voted unanimously on 13 December to recommend that...

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