Posted by Michael Wonder on 17 Dec 2019
Eiger initiates rolling submission of new drug application with FDA for lonafarnib for treatment of progeria and progeroid laminopathies
16 December 2019 - Rolling NDA Submission Planned for Completion in First Quarter 2020.
Eiger BioPharmaceuticals today announced that it has initiated submission of a new drug application for Lonafarnib for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and Progeroid Laminopathies to the U.S. FDA under the rolling review process. Lonafarnib, an oral farnesyltransferase inhibitor (FTI), has demonstrated extended survival in children and young adults with Progeria, an ultra-rare and fatal disease that causes premature ageing in children.
Lonafarnib has been granted orphan drug designation for progeria and progeroid laminopathies by the FDA and EMA and breakthrough therapy designation and rare paediatric disease designation by the FDA.
