Eiger BioPharmaceuticals Receives FDA Acceptance of Zokinvy NDA
Eiger BioPharmaceuticals, Inc. (EIGR) reported that the FDA has accepted its New Drug Application for accelerated review of Zokinvy (lonafarnib) for treating Progeria and Progeroid Laminopathies. The PDUFA for the drug has been set on November 20, 2020. Currently, no proposal has been forwarded by the FDA for holding an advisory committee meeting for discussing the application. The drug candidate has been given the Rare Pediatric Disease tag as well.
Zokinvy is a late-stage, well-characterized, orally active inhibitor of farnesyltransferase, an enzyme responsible for modifying