FDA Rare Pediatric Disease designation for progeria drug

The US Food and Drug Administration has granted Rare Pediatric Disease (RPD) designation to lonafarnib in the treatment of both Hutchinson-Gilford Progeria Syndrome (HGPS or progeria) and progeroid laminopathies, a candidate from US rare diseases specialist Eiger BioPharmaceuticals (Nasdaq: EIGR).

RPD designation for progeria and progeroid laminopathies enables priority review voucher (PRV) eligibility upon FDA approval of a rare pediatric disease product application for lonafarnib for these ultra-rare and fatal genetic conditions characterized by accelerated aging in children. Surprisingly, Eiger’s shares dipped 1.22% to $11.74 on the news this morning.

NDA filing planned for next year