Update for HEPLISAV-B® 4-Dose Regimen for Adults on Hemodialysis

Dynavax Technologies Corporation today announced a regulatory update for the Company's supplemental Biologics License Application (sBLA) to include a four-dose HEPLISAV-B® vaccine regimen for adults on hemodialysis.

Hemodialysis is a renal replacement therapy in which a machine filters a patient's blood when the kidneys are no longer able to do so.

The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) in response to the sBLA, stating that the application did not provide sufficient data to support the full evaluation of the effectiveness or safety of a four-dose regimen of HEPLISAV-B.

The CRL stated that the data from HBV-24 were insufficient due to the destruction of data source documents by a third-party clinical trial site operator for approximately half of the subjects enrolled in the trial. In addition, the total number of subjects in the single-arm HBV-24 study was deemed insufficient to evaluate the safety of the four-dose regimen.

The CRL does not affect the approval decision received from the European Commission in October 2023 for the four-dose HEPLISAV-B regimen for the adult hemodialysis population.

The CRL also has no impact on the approved indication for HEPLISAV-B in the U.S., the European Union, and Great Britain, which is for the prevention of infection caused by all known subtypes of hepatitis B virus in adults.

"We remain confident in the data generated to support HEPLISAV-B vaccination for adult hemodialysis patients. All key data collected in HBV-24 were verified against original source documents during the conduct of the trial," said Rob Janssen, M.D., Chief Medical Officer of Dynavax, in a press release on May 14, 2024.

"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."

On May 9, 2024, the Company announced HEPLISAV-B vaccine net product revenue grew 10% year-over-year to approximately $48 million in the first quarter of 2024. It also reaffirmed the full-year 2024 HEPLISAV-B net product revenue guidance of $265 - $280 million.