FDA rejects expanded use of Dynavax’s four-dose hepatitis B vaccine for hemodialysis

The FDA has declined to approve Dynavax’s supplemental biologics license application for the expanded use of its four-dose hepatitis B vaccine regimen in adult patients on hemodialysis, according to a manufacturer’s press release.

In its complete response letter, the FDA voiced concerns that the application from Dynavax did not provide “sufficient data to support the full evaluation of effectiveness or safety of a four-dose regimen of Heplisav-B.” However, the agency reported no issues with safety and efficacy for the regimen’s current indication.

The Dynavax application was based on clinical immunogenicity and safety data from the phase 1 HBV-24 study, which assessed a four-dose regimen of Heplisav-B in 119 adult patients undergoing hemodialysis as well as five supportive clinical trials in either adults with chronic kidney disease or undergoing dialysis.

However, the FDA cited that data from the HBV-24 trial were “insufficient due to the destruction of data source documents” by a third-party clinical trial site operator for nearly half of the patients enrolled in the trial. The total number of patients included in the remaining single-arm study was not substantial enough to validate the safety of the four-dose regimen.

“We remain confident in the data generated to support Heplisav-B vaccination for adult hemodialysis patients,” Rob Janssen, MD, chief medical officer of Dynavax, said in the release. “All key data collected in HBV-24 were verified against original source documents during the conduct of the trial. We are reviewing the agency’s feedback and intend to request a meeting with the FDA to evaluate options for providing additional data to support the four-dose regimen for this vulnerable patient population in the U.S.”

The company noted the FDA’s decision will not affect the already approved indication for Heplisav-B in the U.S., the European Union and Great Britain – the prevention of infection caused by “all know subtypes” of hepatitis B virus among adult patients aged 18 years and older. Additionally, the CRL will not impact the European Commission’s approval decision in October 2023 for the four-dose Heplisav-B regimen for adult patients on hemodialysis.

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