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Horizon Pharma Sees Mid-2019 BLA For Tepro After Solid Phase III TED Data

 
• By Sten Stovall

Horizon Pharma is on track to file its top pipeline asset for regulatory approval this year after its Phase III confirmatory trial evaluating teprotumumab for the treatment of active thyroid eye disease met primary and secondary endpoints.

Eye
OPTIC Phase III Study Was In thyroid eye disease (TED) • Source: Shutterstock

Shares in Horizon Pharma PLC soared after the Ireland-based specialty pharma said its lead candidate asset had met primary and secondary endpoints in a confirmatory Phase III trial for treating thyroid eye disease (TED), increasing chances teprotumumab will become the first-ever approved treatment for the condition.

Thyroid eye disease a relatively rare and debilitating autoimmune disease of the tissue around the eye associated with Graves' disease,...

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