By Denny Jacob
Dynavax disclosed that the Food and Drug Administration has ruled its application for its hepatitis B vaccine treatment didn't provide sufficient data to support the full evaluation of its effectiveness or safety.
The commercial-stage biopharmaceutical company said the decision came in a letter from the FDA in response to its supplement biologics license application. The ruling pertained to the four-dose Heplisav-B vaccine regimen for adults on hemodialysis.
"We are reviewing the agency's feedback and intend to request a meeting with the FDA to evaluate options for providing additional data to support the four-dose regimen," said Chief Medical Officer Rob Janssen.
Write to Denny Jacob at denny.jacob@wsj.com
(END) Dow Jones Newswires
05-14-24 0907ET