Posted by Michael Wonder on 22 Oct 2018
Eiger BioPharmaceuticals receives FDA rare paediatric disease designation for lonafarnib for the treatment of progeria and progeroid laminopathies and plans NDA filing in 2019
22 October 2018 - Designation enables priority review voucher eligibility upon NDA approval.
Eiger BioPharmaceuticals today announced that the U.S. FDA has granted rare paediatric disease designation to lonafarnib in the treatment of both Hutchinson-Gilford Progeria Syndrome (HGPS or progeria) and progeroid laminopathies. RPD designation for progeria and progeroid laminopathies enables priority review voucher eligibility upon FDA approval of a rare paediatric disease product application for lonafarnib for these ultra-rare and fatal genetic conditions characterised by accelerated ageing in children.
Eiger is collaborating with The Progeria Research Foundation in this lonafarnib program and plans to submit a new drug application to the FDA in 2019. There is no approved treatment for progeria or progeroid laminopathies.
