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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
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
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.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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