Dynavax Gets FDA Green Light to Resume Its Heplisav Study

Dynavax Technologies will resume a Phase III study of its hepatitis B vaccine Heplisav soon because the FDA has lifted an 18-month clinical hold on testing in patients with chronic kidney disease. The FDA imposed a clinical hold on two applications for Heplisav in March 2008 after a patient in a Phase III clinical trial outside the U.S. was diagnosed as having Wegener’s granulomatosis, a disease that affects blood vessels, Dynavax and then-development partner Merck said.
Clinical Trials Advisor