US FDA declines to approve expanded use of Dynavax's hepatitis B vaccine (updated)

Dynavax Technologies

14/05/2024 13:55

(Adds details in paragraphs 2,4,5, share movement in paragraph
3)
       May 14 (Reuters) - Dynavax Technologies  DVAX.O  said on
Tuesday the U.S. Food and Drug Administration (FDA) has declined
to approve the expanded use of its hepatitis B vaccine in
patients undergoing hemodialysis, citing insufficient safety and
effectiveness data.
    The FDA, in its so-called "complete response letter", stated
that the data was insufficient as a third-party clinical trial
site operator had destroyed data source documents for about half
of the subjects enrolled in the vaccine's trial, according to
the company.
    Shares of the California-based company fell more than 7% in
premarket trading.
    Dynavax's vaccine, Heplisav-B, was first approved by the FDA
in 2017, having been rejected twice before in 2013 and 2016 over
unresolved safety concerns.
    The agency's latest decision will make it harder for the
company to implement its plans to expand the total addressable
market for its lead commercial asset.
    

 (Reporting by Christy Santhosh and Pratik Jain in Bengaluru;
Editing by Tasim Zahid and Shilpi Majumdar)
 ((Christy.Santhosh@thomsonreuters.com;))