EMA's Advisory Committee Recommends Eiger's Zokinvy In Premature Aging Disorder

  • The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending Eiger BioPharmaceuticals Inc's EIGR Zokinvy for Hutchinson-Gilford progeria syndrome (HGPS) and processing-deficient progeroid laminopathies (PL).
  • HGPS and PL are ultra-rare and fatal pediatric diseases that cause dramatically accelerated aging and premature death. 
  • The CHMP based its decision on two clinical trials, which showed that Zokinvy lowered the risk of death in children with HGPS by 72%. 
  • Zokinvy extended life by an average of 4.3 years in children and young adults with HGPS. 
  • Based on the CHMP recommendation, a decision by the European Commission is anticipated within approximately two months.
  • Zokinvy was approved in the U.S. in November 2020 to reduce the risk of death in Hutchinson-Gilford progeria syndrome and to treat processing-deficient progeroid laminopathies. It is indicated for adults and children over 12 months of age. 
  • This month, Eiger announced a strategic partnership with AnGes to seek regulatory approval and commercialization of Zokinvy in Japan.
  • Price Action: EIGR shares are down 2.95% at $6.60 during the market session on the last check Friday.
Posted In: BriefsBiotechNewsHealth CareGeneral