A wider Horizon beckons in thyroid eye disease

 Horizon’s Tepezza was approved in all thyroid eye disease patients in 2020, but payers had other ideas, and the IGF-1R antibody is currently only reimbursed in those with severe disease. New data released yesterday could change that, with a postmarketing trial showing that Tepezza reduced proptosis – the characteristic eye bulging seen in TED – in patients with mild disease. The point is important: Horizon estimates that around 20,000 US patients are diagnosed with acute TED each year, whereas around 70,000 have the chronic form. Questions remain, principally whether these data actually will prompt payers to broaden coverage, particularly since a six-month course of Tepezza typically costs over $300,000, SVB analysts write. The 25% placebo responder rate seen in the intent-to-treat analysis is also an eyebrow-raiser. These are all future considerations for Amgen, which agreed to buy Horizon late last year for $28bn – assuming FTC clearance is granted. Evercore ISI analysts point out that Tepezza sales need to hit $4bn+ for Amgen to break even on the deal, ramping up from the current $2bn run rate. And competition is looming from Viridian, which is due to report phase 2 data in chronic TED later this quarter.

Phase 4 trial (NCT04583735) data
Endpoint	Population	Tepezza	Placebo	p-value
Reduction in proptosis (primary endpoint)	Intent-to-treat	2.41mm	0.92mm	0.0004
	Per protocol	2.44mm	0.69mm	0.0006
Proptosis response rate	Intent-to-treat	62%	25%	0.0134
	Per protocol	63%	7%	0.0008
Proptosis response defined as reduction of at least 2mm. All data at 24wks. Source: company release. https://www.evaluate.com/vantage/articles/news/trial-results-snippets/wider-horizon-beckons-thyroid-eye-disease