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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: lonafarnib
Trade Name: ZOKINVY
Date Designated: 04/18/2011
Orphan Designation: Treatment of Hutchinson-Gilford progeria syndrome and progeroid laminopathies
Orphan Designation Status: Designated/Approved
Eiger BioPharmaceuticals, Inc.
2155 Park Boulevard
Palo Alto, California 94306
United States

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

Marketing approved:

1 Generic Name: lonafarnib
Trade Name: ZOKINVY
Marketing Approval Date: 11/20/2020
Approved Labeled Indication: in patients 12 months of age and older with a body surface area (BSA) of 0.39 m2 and above (1) to reduce the risk of mortality in Hutchinson-Gilford Progeria Syndrome (HGPS); and (2) for the treatment of processing-deficient Progeroid Laminopathies with either heterozygous LMNA mutation with progerin-like protein accumulation or homozygous or compound heterozygous ZMPSTE24 mutations
Exclusivity End Date: 11/20/2027 
Exclusivity Protected Indication* :  in patients 12 months of age and older with a body surface area (BSA) of 0.39 m2 and above: (1) to reduce the risk of mortality in Hutchinson-Gilford Progeria Syndrome (HGPS); and (2) for the treatment of processing-deficient Progeroid Laminopathies with either heterozygous LMNA mutation with progerin-like protein accumulation or homozygous or compound heterozygous ZMPSTE24 mutations
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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