EMERYVILLE, California, May 14, 2024 /PRNewswire/ — Dynavax Technologies Corporation (Nasdaq: DVAX) today provided a regulatory update for the company’s Supplemental Biologics License Application (sBLA) to include a four-dose HEPLISAV-B vaccine [Hepatitis B Vaccine (Recombinant), Adjuvanted] regimen for adults on hemodialysis. The US 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 efficacy or safety of a four-dose regimen of HEPLISAV. -B. The CRL has no impact on the approved indication for HEPLISAV-B in the US, the European Union and Great Britain, which is for the prevention of infection caused by all known subtypes of the 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 a October 2023 for the four-dose regimen of HEPLISAV-B for the adult hemodialysis population.
The sBLA consisted of immunogenicity and clinical 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 supporting clinical trials of HEPLISAV-B in adults with chronic kidney disease. disease or undergoing hemodialysis. The CRL declared the HBV-24 data to be 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 assess the safety of the four-dose regimen.
“We are 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 documents during the conduct of the trial,” said Rob Janssen , MD, Medical Director. from Dynavax. “We are reviewing the agency’s comments 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 US.”
Important US product information
HEPLISAV-B is indicated for the prevention of infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older.
For complete US prescribing information for HEPLISAV-B, click here.
US Important Security Information (ISI)
Do not give HEPLISAV-B to people with a history of a severe allergic reaction (eg, anaphylaxis) after a previous dose of any hepatitis B vaccine or any component of HEPLISAV-B, including yeast.
Adequate medical treatment and supervision should be available to manage potential anaphylactic reactions following administration of HEPLISAV-B.
Immunocompromised persons, including persons receiving immunosuppressive therapy, may have a decreased immune response to HEPLISAV-B.
Hepatitis B has a long incubation period. HEPLISAV-B may not prevent hepatitis B infection in people who have unrecognized hepatitis B infection at the time of vaccine administration.
The most common patient-reported adverse reactions within 7 days of vaccination were injection site pain (23% to 39%), fatigue (11% to 17%), and headache (8% to 17% ).
About Dynavax
Dynavax is a commercial-stage biopharmaceutical company that develops and markets innovative vaccines to help protect the world against infectious diseases. The company has two commercial products, the HEPLISAV-B vaccine [Hepatitis B Vaccine (Recombinant), Adjuvanted]which is approved in the USA, the European Union and Great Britain for the prevention of infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older, and the adjuvant CpG 1018, which is currently used in HEPLISAV-B vaccines and multiple adjuvants against the COVID-19. Dynavax is advancing CpG adjuvant 1018 as a lead vaccine adjuvant with shingles and Tdap adjuvanted vaccine clinical programs, and through global collaborations, currently focused on adjuvanted vaccines for COVID-19, plague, seasonal flu and universal flu. For more information on our marketed products and development pipeline, please visit www.dynavax.com.
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 generally can be identified by the use of words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “anticipate,” “attempt,” “will will love,” ” “may”, “plan”, “project”, “potential”, “seek”, “should”, “think”, “to”, “will”, “would” and similar expressions, or their negatives , or may use future dates. Forward-looking statements made in this document include statements about requests for future meetings with the FDA and the timing or potential outcome of such meetings. Actual results may differ materially from those set forth in this release press release due to the risks and uncertainties inherent in our business, including the availability, time and cost associated with any potential follow-up study or additional trial, the FDA’s availability and willingness 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 since then, as well as discussions of potential risks, uncertainties and other important factors in our other filings with the US Securities and Exchange Commission. These forward-looking statements are made as of the date hereof, are qualified in their entirety by this cautionary statement, and we undertake no obligation to revise or update the information herein to reflect future events or circumstances, even if new information is available. Information on Dynavax’s website at www.dynavax.com is not incorporated by reference into our current periodic filings with the SEC.
For investors/media:
Paul Cox
[email protected]
510-665-0499
Nicole Arndt
[email protected]
510-665-7264
SOURCE Dynavax Technologies
#Dynavax #Regulatory #Update #sBLA #HEPLISAVB #FourDose #Regimen #Adults #Hemodialysis
Image Source : www.prnewswire.com