Dynavax's Hep B Vaccine Finally Clears US FDA With Clean Label But Larger Safety Study

13 Nov 2017

Heplisav-B labeling notes myocardial infarction imbalance in one trial but also apparent absence of a causal relationship; sponsor will conduct a postmarketing safety cohort study involving 50,000 subjects, 10,000 more than initially planned.

Red Approved Stamp with Wooden handle Rubber Stamper Isolated on White Background.

After several failed attempts at US regulatory approval, Dynavax Technologies Corp.'s hepatitis B vaccine Heplisav-B will finally enter the market in early 2018 with a relatively clean label but a postmarketing study that is 25% larger than originally proposed.

On Nov. 9, FDA licensed Heplisav-B (hepatitis B vaccine [recombinant] adjuvanted) for prevention of infection caused by all known subtypes...