Dynavax plans Phase III for hepatitis B vaccine after FDA hold lifted
This article was originally published in Scrip
Executive Summary
Dynavax plans to soon initiate a pivotal Phase III trial testing its investigational hepatitis B vaccine, Heplisav, in chronic kidney disease patients, as well as a second Phase III trial in healthy adults aged over 40 in early 2010. The moves come after the US FDA lifted its clinical hold on the vaccine following a refinement of the company's strategy to address these populations first.