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Heplisav’s Hopes For U.S. Approval Could Rest On Narrower Population

 
• By Sue Sutter

In a “complete response” letter for the novel, adjuvanted hepatitis B vaccine, FDA cites the need for more safety data in the broad population of adults for which approval was sought; however, Dynavax says the agency appears open to considering a more restricted use, such as in patients with chronic kidney disease.

Dynavax Technologies Corp. is eyeing narrower populations – including chronic kidney disease patients and individuals ages 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...

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