- FDA sets a target action date of November 30, 2021
VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced that the U.S. Food and Drug Administration (FDA) has accepted its filing of the Biologics License Application (BLA) for the Company’s 3-antigen prophylactic hepatitis B vaccine candidate for the prevention of infection caused by all known subtypes of the hepatitis B virus (HBV) in adults. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of November 30, 2021.
“The FDA acceptance of our BLA represents a significant milestone for VBI, but more importantly for the effort to provide broad access to this vaccine, which we believe has the potential to be a meaningful intervention for adults in the fight against hepatitis B,” said Jeff Baxter, President & CEO. “Progress in preventing HBV infection has stalled, and the 11 percent increase in U.S. acute cases from 2014 to 2018 highlights the need for renewed focus, innovation, and action in the space. We are committed to working with the FDA throughout their review process over the course of this year as we work to address this serious, but preventable, public health threat.”
Additionally, in the filing notification letter, the FDA communicated that it is not currently planning to hold an advisory committee meeting to discuss the application.
The BLA is supported by data from the two pivotal, randomized, double-blind, controlled Phase 3 studies – PROTECT and CONSTANT – in addition to other relevant data. The studies were designed to assess the efficacy and safety of VBI’s 3-antigen HBV vaccine compared with Engerix-B®, as well as the lot-to-lot manufacturing consistency of VBI’s vaccine.
About Hepatitis B
Hepatitis B is one of the world’s most significant infectious disease threats with more than 290 million people infected globally. HBV infection is the leading cause of liver disease and, with current treatments, it is very difficult to cure, with many patients going on to develop liver cancers. An estimated 780,000 people die each year from complications of chronic HBV such as liver decompensation and hepatocellular carcinoma.
About VBI’s 3-Antigen Hepatitis B Vaccine
VBI’s vaccine candidate is the only 3-antigen hepatitis B vaccine, comprised of the S, pre-S1, and pre-S2 surface antigens of the hepatitis B virus, and is approved for use and commercially-available in Israel. In December 2017, VBI initiated patient dosing in a global Phase 3 clinical program that consisted of two concurrent pivotal studies: PROTECT, a safety and immunogenicity study, and CONSTANT, a lot-to-lot consistency study. Data from both the PROTECT study and the CONSTANT study, which were announced in June 2019 and January 2020, respectively, comprise the basis for the regulatory submissions in the U.S., Europe, and Canada. This vaccine is sold under the name Sci-B-Vac® in Israel.
To learn more about VBI’s 3-Antigen Hepatitis B vaccine visit: https://www.vbivaccines.com/sci-b-vac/