Posted by Michael Wonder on 23 Mar 2020
Eiger BioPharmaceuticals completes submission of new drug application to FDA for lonafarnib for treatment of progeria and progeroid laminopathies
23 March 2020 - Progeria MAA submitted to EMA and granted accelerated assessment.
Eiger BioPharmaceuticals today announced that it has completed submission to the U.S. FDA of a new drug application for lonafarnib for the treatment of progeria and progeroid laminopathies.
The FDA previously granted breakthrough therapy designation and rare paediatric disease designation to lonafarnib, which enables eligibility for priority review, if relevant criteria are met. Eiger expects to hear from FDA regarding submission acceptance and Priority Review within 60 days.
