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 (NASDAQ: 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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