Lowers the risk of mortality in Hutchinson-Gilford Progeria Syndrome (HGPS). NDA 213969, held by Sentynl Theraps Inc. Lonafarnib.
As of Nov 14, 2026, NDA 213969 (Zokinvy), held by Sentynl Theraps Inc, was first approved by FDA on Nov 20, 2020, with 2 approved supplements and 0 published complete response letters.
ZOKINVY is indicated in patients 12 months of age and older with a body surface area (BSA) of 0.39 m 2 and above: To reduce the risk of mortality in Hutchinson-Gilford Progeria Syndrome (HGPS) For the treatment of processing-deficient Progeroid Laminopathies with either: Heterozygous LMNA mutation with progerin-like protein accumulation Homozygous or compound heterozygous ZMPSTE24 mutations
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 20, 2020 | Original applicationNew molecular entity · Priority review | Approved |
| Zokinvy50MG · capsule;oral | Lonafarnib | RxReference drug |
| Zokinvy75MG · capsule;oral | Lonafarnib | RxReference drug |
| Mar 21, 2024 | Supplement 3Labeling · Standard review | Approved | |
| Mar 21, 2024 | Supplement 2Labeling · Standard review | Approved | |
| Nov 20, 2020 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
