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.
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The latest drug approval and development news from our US FDA Performance Tracker.
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.
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.