The European Commission has granted a conditional marketing authorization to ERVEBO, an investigational V920 Ebola Zaire vaccine.
NewLink Genetics (NASDAQ:NLNK) has announced that the European Commission (EC) has granted a conditional marketing authorization to the company’s ERVEBO V920 ebola zaire vaccine confirmed by its partner Merck (NYSE:MRK).
As quoted in the press release:
With this approval, the EC will grant a centralized marketing authorization for the vaccine with unified labeling that is valid in 31 European countries.
The granting of this approval by the EC follows the September 17th announcement by the FDA that it has accepted the Biologics License Application (BLA) and granted priority review for the investigational Ebola vaccine (V920). The Prescription Drug User Fee Act (PDUFA), or target FDA action date, is set for March 14, 2020. As NewLink has previously stated, the FDA’s approval of this Ebola vaccine would trigger the issuance of a priority review voucher owned by Merck and in which NewLink Genetics has a substantial economic interest. Thereafter, NewLink would have the right to monetize its share of interest in the voucher.
“We are thrilled by the EC’s decision to approve this Ebola vaccine, offering the potential for protection from this devastating disease,” noted Eugene Kennedy, MD, Chief Medical Officer and member of NewLink Genetics’ Office of the CEO. “We are also grateful to our partner Merck, and to the regulatory bodies involved for their diligent efforts to advance solutions to combat this deadly illness.”