Horizon Therapeutics’ Tepezza (teprotumumab-trbw) Receives the US FDA’s Approval as the First Therapy for Thyroid Eye Disease

Shots:

• The US FDA’s approval of Tepezza is based on P-II study and P-III OPTIC study assessing Tepezza vs PBO in patients with thyroid eye disease. Tepezza was initially developed by River Vision and Roche, later Horizon acquired River Vision and will pay ~$105M as milestones in H1’2020   
• The P-III OPTIC study results: @24wks, improvement in proptosis (≥ 2 mm) (82.9% vs 9.5%) without deterioration in the fellow eye; change in at least one grade in diplopia (67.9% vs 28.6%). Pooled analysis demonstrated complete resolution of diplopia (53% vs 25%)
• Tepezza (q3w, for 8 infusions) is mAb targeting IGF-1R and has received the US FDA’s PR, ODD, BT designation with its anticipated PDUFA date as 08 Mar, 2020. The therapy is expected to be available in the US in the coming wks.

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