FDA Declines To Approve Expanded Use of Dynavax's Hepatitis B Vaccine In Hemodialysis Patients

Tuesday, Dynavax Technologies Corporation DVAX provided a regulatory update for its supplemental Biologics License Application (sBLA) to include a four-dose HEPLISAV-B vaccine regimen for adults on hemodialysis. 

The FDA has issued a Complete Response Letter stating that the application did not provide sufficient data to fully evaluate the effectiveness or safety of a four-dose regimen of HEPLISAV-B. 

The CRL has no impact on the approved indication for HEPLISAV-B in the U.S., the European Union, and Great Britain, which prevents infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older. 

The CRL also 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 supplemental application included clinical immunogenicity and safety data from the Phase 1 HBV-24 study of a four-dose regimen of HEPLISAV-B in 119 adults undergoing hemodialysis, as well as five supportive clinical trials of HEPLISAV-B in adults with chronic kidney disease or undergoing hemodialysis. 

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 four-dose regimen’s safety.

“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.,” said Rob Janssen, Dynavax’s Chief Medical Officer.

In first quarter 2024, HEPLISAV-B vaccine achieved net product revenue of $47.8 million up from $43.5 million a year ago.

HEPLISAV-B total estimated market share in the U.S. increased to approximately 41%, compared to approximately 37% at the end of the first quarter 2023.

Price Action: At last check on Tuesday, DVAX shares were down 1.36% at $10.88.