Search Orphan Drug Designations and Approvals
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| Generic Name: | lonafarnib | ||||||||||||||||
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| Trade Name: | ZOKINVY | ||||||||||||||||
| Date Designated: | 04/18/2011 | ||||||||||||||||
| Orphan Designation: | Treatment of Hutchinson-Gilford progeria syndrome and progeroid laminopathies | ||||||||||||||||
| Orphan Designation Status: | Designated/Approved | ||||||||||||||||
| Sponsor: |
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. |
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Marketing approved: |
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| 1 | Generic Name: | lonafarnib |
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| 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 | |
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