Eiger announces Breakthrough Therapy designation for lonafarnib
Eiger BioPharmaceuticals announced that the Food and Drug Administration has granted Breakthrough Therapy designation for lonafarnib for the treatment of Hutchinson-Gilford progeria syndrome and progeroid laminopathies. FDA Breakthrough Therapy designation is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases. Progeria and progeroid laminopathies are ultra-rare, genetic conditions characterized by accelerated aging, with no approved treatment. Eiger is collaborating with The Progeria Research Foundation and plans to submit a new drug application to the FDA in 2019. Lonafarnib is a first-in-class prenylation inhibitor for the treatment for Progeria and progeroid laminopathies.This Breakthrough Therapy designation is supported by data from clinical studies of lonafarnib, demonstrating statistically significant improvements in survival in children with Progeria where the average survival age without treatment is 14.5 years.