The Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) and granted priority review for V920, an investigational Ebola vaccine in development by Merck.
The BLA was supported by data from a phase 3 study assessing the vaccine in 1197 healthy adults who had antibody response assessed pre-, and post-vaccination with different consistency lots of V920.
Findings from the study showed that the geometric mean titers of anti-Zaire ebolavirus envelope (ZEBOV) glycoprotein antibody (primary end point) increased in all the groups post-vaccination and persisted through 24 months. More than 94% of vaccine recipients seroresponded at Day 28; responses persisted through 24 months in ≥91%.
Further analysis showed that being female and having a history of arthritis were both associated with an increased risk of developing arthritis post-vaccination.
The Prescription Drug User Fee Act (PDUFA) target date for V920 has been set for March 14, 2020.
“A top priority for us remains achieving registration of V920 and regulatory approval of our German manufacturing site, so that licensed supply can be produced over time to support global public health preparedness and health security objectives,” said Dr Paula Annunziato, vice president, Merck Research Laboratories. “We look forward to continuing to work with the FDA throughout the review process.”
For more information visit Merck.com.