Dynavax Technologies Corp. is eyeing narrower populations – including chronic kidney disease patients and individuals 40 years and older – as a potential route to approval for its novel, adjuvanted hepatitis B vaccine Heplisav now that FDA has issued a “complete response” letter for broad use in adults.
On Feb. 25, one day after the vaccine’s user fee date, Dynavax announced that FDA had declined to approve Heplisav (rHBsAg-1018 ISS) for adults aged 18-70 years. The “complete response”...
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