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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: evinacumab-dgnb
Trade Name: Evkeeza
Date Designated: 02/08/2016
Orphan Designation: Treatment of homozygous familial hypercholesterolemia
Orphan Designation Status: Designated/Approved
Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road
Tarrytown, New York 10591-6707
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: evinacumab-dgnb
Trade Name: Evkeeza
Marketing Approval Date: 02/11/2021
Approved Labeled Indication: adjunct to other low-density lipoprotein-cholesterol (LDL-C) lowering therapies for the treatment of adult and pediatric patients, aged 12 years and older, with homozygous familial hypercholesterolemia (HoFH)
Exclusivity End Date: 02/11/2028 
Exclusivity Protected Indication* :  adjunct to other low-density lipoprotein-cholesterol (LDL-C) lowering therapies for the treatment of adult and pediatric patients, aged 12 years and older, with homozygous familial hypercholesterolemia (HoFH)
2 Generic Name: evinacumab-dgnb
Trade Name: Evkeeza
Marketing Approval Date: 03/21/2023
Approved Labeled Indication: as an adjunct to other low-density lipoprotein-cholesterol (LDL-C) lowering therapies for the treatment of adult and pediatric patients, aged 5 years and older, with homozygous familial hypercholesterolemia (HoFH)
Exclusivity End Date: 03/21/2030 
Exclusivity Protected Indication* :  as an adjunct to other low-density lipoprotein-cholesterol (LDL-C) lowering therapies for the treatment of pediatric patients, aged 5 years to less than 12 years, with homozygous familial hypercholesterolemia (HoFH)
3 Generic Name: evinacumab-dgnb
Trade Name: Evkeeza
Marketing Approval Date: 09/25/2025
Approved Labeled Indication: as an adjunct to diet and exercise and other low-density lipoprotein-cholesterol (LDL-C) lowering therapies to reduce LDL-C in adults and pediatric patients, aged 1 year and older, with homozygous familial hypercholesterolemia (HoFH)
Exclusivity End Date: TBD  
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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