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Postmarketing Trial For Horizon Thyroid Eye Drug Tepezza To Be Larger Than Expected

 
• By Derrick Gingery

Horizon CEO says safety trial will be conducted in a larger patient population following discussions during the US FDA advisory committee meeting.

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As part of its postmarketing requirements, Horizon must also complete the ongoing OPTIC-X trial, which is expected later this year. • Source: Shutterstock

Horizon Therapeutics PLC may have been forced to conduct a larger postmarket study than expected for its newly approved Tepezza following advisory committee concerns the proposed size was not sufficient.

Tepezza (teprotumumab-trbw) was approved 21 January, the first US Food and Drug Administration-cleared product for thyroid eye disease (TED), a rare disease associated with

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