Dynavax Provides Regulatory Update on sBLA for Four-Dose HEPLISAV-B® Regimen for Adults on Hemodialysis in the U.S.
Dynavax Technologies (Nasdaq: DVAX) announced that the U.S. FDA has issued a Complete Response Letter (CRL) regarding its supplemental Biologics License Application (sBLA) for a four-dose HEPLISAV-B vaccine regimen for adults on hemodialysis. The CRL cited insufficient data to fully evaluate the effectiveness and safety of the regimen, due to the destruction of data source documents and an inadequate sample size in the HBV-24 study. This decision does not impact the current approved indications for HEPLISAV-B in the U.S., EU, and Great Britain, nor the European Commission's approval of the four-dose regimen for hemodialysis patients. Dynavax plans to meet with the FDA to explore options for providing additional data.
- The CRL does not affect the existing approved indication for HEPLISAV-B in the U.S., EU, and Great Britain.
- The European Commission has already approved the four-dose HEPLISAV-B regimen for adult hemodialysis patients.
- Dynavax remains confident in the data generated from the HBV-24 study and is proactive in seeking a meeting with the FDA to address the CRL.
- The FDA's CRL indicates insufficient data to support the full evaluation of HEPLISAV-B's four-dose regimen for adults on hemodialysis.
- Data source documents for approximately half of the subjects in the HBV-24 study were destroyed by a third-party clinical trial site operator.
- The total number of subjects in the HBV-24 study was deemed insufficient to evaluate the safety of the four-dose regimen.
Insights
The FDA's issuance of a Complete Response Letter (CRL) to Dynavax's supplemental Biologics License Application (sBLA) for the four-dose HEPLISAV-B regimen signals a regulatory setback. This decision is significant because it delays potential revenue streams that Dynavax would have garnered from the expanded indication. Although the CRL does not impact the currently approved use of HEPLISAV-B, it highlights potential weaknesses in Dynavax's clinical data collection and management. Regulatory delays can increase costs and affect investor sentiment negatively. In the short term, Dynavax may experience a stock price decline due to this announcement, but their existing approvals in the U.S., EU and Great Britain provide some buffer.
The FDA's feedback focuses on the insufficiency of clinical data due to the loss of source documents and the small sample size in the HBV-24 study. This indicates a need for more robust data collection practices and possibly larger, more comprehensive studies to satisfy regulatory requirements. The destruction of data by a third-party operator emphasizes the importance of data integrity in clinical trials. For stakeholders, this implies that Dynavax may need additional time and resources to generate the necessary data, postponing the potential benefits of the expanded vaccine indication. Investors should be aware of the extended timeline and possibly increased R&D costs.
For patients undergoing hemodialysis, the four-dose regimen of HEPLISAV-B was designed to offer enhanced immunogenicity. Despite the current setback, it's important to note that Dynavax's existing HEPLISAV-B vaccine already serves adult populations effectively, including those receiving hemodialysis. The CRL's focus on data integrity does not necessarily cast doubt on the vaccine's efficacy or safety but rather on the process by which supporting data were gathered. Improved data collection and larger trials will be important moving forward to meet the FDA's stringent standards, ensuring that vulnerable patients receive the best possible care.
The sBLA was comprised of 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 to be insufficient to evaluate safety of the four-dose regimen.
"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. "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
Important U.S. Product Information
HEPLISAV-B is indicated for the prevention of infection caused by all known subtypes of hepatitis B virus in adults aged 18 years and older.
For full U.S. Prescribing Information for HEPLISAV-B, click here.
Important U.S. Safety Information (ISI)
Do not administer HEPLISAV-B to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast.
Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV-B.
Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to HEPLISAV-B.
Hepatitis B has a long incubation period. HEPLISAV-B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration.
The most common patient-reported adverse reactions reported within 7 days of vaccination were injection site pain (
About Dynavax
Dynavax is a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines to help protect the world against infectious diseases. The Company has two commercial products, HEPLISAV-B® vaccine [Hepatitis B Vaccine (Recombinant), Adjuvanted], which is approved in the
Forward-Looking Statements
This press release contains "forward-looking" statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to a number of risks and uncertainties. All statements that are not historical facts are forward-looking statements. Forward-looking statements can generally be identified by the use of words such as "anticipate," "believe," "continue," "could," "estimate," "expect," "forecast," "intend," "will," "may," "plan," "project," "potential," "seek," "should," "think," "toward," "will," "would" and similar expressions, or the negatives thereof, or they may use future dates. Forward-looking statements made in this document include statements regarding requests for future meetings with the FDA and the potential timing or outcome of those meetings. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including, the availability, time and cost associated with any potential follow up studies or additional trials, availability and willingness of the FDA to meet, and the uncertainty of whether these efforts will achieve our desired results, as well as other risks detailed in the "Risk Factors" section of our Quarterly Report on Form 10-Q for the three months ended March 31, 2024 and periodic filings made thereafter, as well as discussions of potential risks, uncertainties and other important factors in our other filings with the
For Investors/Media:
Paul Cox
pcox@dynavax.com
510-665-0499
Nicole Arndt
narndt@dynavax.com
510-665-7264
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SOURCE Dynavax Technologies
FAQ
What was the FDA's response to Dynavax's sBLA for the four-dose HEPLISAV-B regimen?
Does the CRL affect the current approved indications for HEPLISAV-B in the U.S.?
Why did the FDA consider the data from the HBV-24 study insufficient?
Has the four-dose HEPLISAV-B regimen been approved in any region?
What are Dynavax's next steps following the FDA's CRL?
