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

Zinger Key Points
  • HBV-24 data were insufficient due to destroyed data source documents for approximately half of the subjects enrolled in the trial. 
  • Also, the total number of subjects in the single-arm HBV-24 study was deemed insufficient to evaluate the four-dose regimen's safety.

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.

Market News and Data brought to you by Benzinga APIs
Posted In: BiotechNewsHealth CareFDAMoversTrading IdeasGeneralBriefsStories That Matterwhy it's moving
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!