Heplisav Seems Headed For Approval, But With More Robust Postmarketing Study
Safety of Dynavax's hepatitis B vaccine gets thumbs up from US FDA advisory committee, but panel remained concern that postmarketing proposal doesn't address questions about potential link to cardiovascular events.
You may also be interested in...
Keeping Track: A Massive Week Of Agency Approvals
The latest drug approval and development news from our US FDA Performance Tracker.
Dynavax's Hep B Vaccine Finally Clears US FDA With Clean Label But Larger Safety Study
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.
Heplisav Postmarketing Worries Push PDUFA Date Back; FDA Seeks More Details
Dynavax's final pivotal trial for hepatitis B candidate was missing data from 150 patients, making its causality of myocardial infarctions unclear; the question now is whether the postmarketing trial can answer the question.