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# Eiger Bio NDA for Zokinvy
- URL: https://www.fdaweb.com/eiger-bio-nda-for-zokinvy/
- Published: 2020-05-19T12:00:00.000Z
- Updated: 2026-09-14T16:15:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146820

FDA has accepted for accelerated review an Eiger BioPharmaceuticals NDA for Zokinvy (lonafarnib) for treating Progeria and Progeroid Laminopathies. The agency set a user fee review action target date of 11/20, and Eiger says it was told that an advisory committee meeting to discuss the application is not being planned.

Progeria is an ultra-rare and fatal genetic condition that causes accelerated aging in children. It is caused by a point mutation in the LMNA gene, which encodes the lamin A protein, the company says. Progeroid Laminopathies are genetic conditions also leading to accelerated aging caused by a constellation of mutations in the lamin A and/Zmpste24 genes, it says.

The submission includes data from a study published in *Journal of the American Medical Association that “*demonstrated a survival benefit with an 88% reduction in the risk of mortality in patients with Progeria treated with lonafarnib monotherapy,” the company says. The most commonly reported adverse events with the drug are gastrointestinal in nature, it adds.