Datapoint: Regeneron’s Evkeeza Scores First-in-Class Approval for Ultra-Rare Heart Disease

The FDA on Feb. 11 approved Regeneron Pharmaceuticals, Inc.’s Evkeeza as an adjunct treatment to other low-density lipoprotein lowering therapies in patients 12 and older with homozygous familial hypercholesterolemia (HoFH), an ultra-rare genetic form of high cholesterol. This is Regeneron’s first cholesterol win since its 2015 launch of Praluent. Praluent (a joint venture with Sanofi) is not approved to treat HoFH, unlike PCSK9 rival Repatha, an Amgen stalwart. For the treatment of HoFH, Repatha holds preferred formulary placement for 2% of all covered lives, growing to 51% with utilization management restrictions applied.

SOURCE: MMIT Analytics, as of 2/22/21

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