NewLink Genetics Announces EU Regulatory Committee (CHMP) Recommendation for Conditional Marketing Authorization for Ebola Vaccine V920 (ERVEBO®)
AMES, Iowa, Oct. 21, 2019 (GLOBE NEWSWIRE) -- NewLink Genetics Corporation (NASDAQ:NLNK) announced today that Friday, October 18th, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a conditional marketing authorization for investigational V920 Ebola Zaire vaccine (rVSV∆G-ZEBOV-GP), as confirmed by our partner, Merck & Co., Inc. (NYSE:MRK). This Committee recommendation will now be reviewed by the European Commission (EC) which, if it chooses to affirm the CHMP’s recommendation, will grant a centralized marketing authorization of the vaccine (brand name ERVEBO®) under a unified label valid in 31 European countries.
This opinion issued by the CHMP follows the recent announcement by the FDA that it has accepted the Biologics License Application (BLA) and granted priority review for the investigational Ebola vaccine (V920). As previously reported, the Prescription Drug User Fee Act (PDUFA), or target FDA action date, is set for March 14, 2020. Should this vaccine be approved by the FDA, a monetizable Priority Review Voucher (PRV) would be issued, in which NewLink Genetics owns a substantial financial interest.
“We are delighted by this EMA Committee opinion supporting the conditional marketing authorization of our partnered Ebola virus vaccine,” commented Carl Langren, Chief Financial Officer and member of NewLink Genetics’ Office of the CEO. “We believe the Committee’s positive opinion represents further recognition of the critical nature of this Ebola outbreak and signifies the urgency with which regulatory bodies are addressing the severe risk this disease poses to a worldwide population.”
About NewLink Genetics Corporation
NewLink Genetics is a clinical stage biopharmaceutical company focused on developing novel oncology product candidates to improve the lives of patients with cancer where treatment options are limited. NewLink Genetics' IDO pathway inhibitors, indoximod and its prodrug, NLG802, are immuno-oncology drug candidates designed to harness multiple components of the immune system to combat cancer. For more information, please visit www.NewLinkGenetics.com.
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Source: NewLink Genetics Corporation