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.

Click here ­to­ read full press release/ article | Ref: Horizon Therapeutics | Image: Horizon Therapeutics