Merck Returns Heplisav To Dynavax After FDA Rules Vaccine Too Risky For Healthy Adults
This article was originally published in The Pink Sheet Daily
Regulators offer option to proceed with the hepatitis B vaccine in kidney disease patients, but can the company bear the risk/cost burden of going it alone until it can repartner?
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Hepatitis B vaccine's favorable efficacy data relative to GSK's Engerix-B and neutral safety language mean that any partnership opportunity 'would need to be a highly attractive one to alter our current course,' Dynavax CEO Gray says.
FDA calls off November meeting to give 'more time to review and resolve several outstanding issues' with adjuvanted hepatitis B vaccine; Dynavax says agency determined meeting was not necessary to ensure regulatory decision by Dec. 15 goal date.
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.