- 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.
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