Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Sold as Evkeeza. Every FDA application for this active ingredient.
As of Nov 14, 2026, FDA lists 1 application for Evinacumab-Dgnb (sold as Evkeeza), first approved Feb 11, 2021, with 2 new uses approved and 0 published complete response letters.
First approved: Feb 11, 2021
Applications: 1
New uses approved: 2
Complete response letters: 0
Medicare spending, 2025: $52.7M
Orphan exclusivity until: Sep 25, 2032
First approved in the EU: Jun 17, 2021
First approved in Japan: Jan 18, 2024
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 35 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
Evkeeza, new ingredientA drug with a new active ingredient indicated for the treatment of homozygous familial hypercholesterolemia. · Ultragenyx Japan K.K. · Jan 18, 2024
Applications
NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
Regeneron Pharmaceuticals