- Category: HBV Vaccines
- Published on Wednesday, 27 June 2012 00:00
- Written by Press Release
The U.S. Food and Drug Administration (FDA) has indicated that it will review for approval a new hepatitis B vaccine known as Heplisav.
Widespread immunization against hepatitis B virus (HBV) -- now part of the routine childhood vaccination series in the U.S. and much of the world -- has dramatically reduced infection rates over the past 2 decades. But researchers continue to work on new vaccines that are more effective and easier to administer.
Below is an edited excerpt from a Dynavax press release announcing the FDA's acceptance of its Heplisav review application.
Dynavax Announces FDA Acceptance of HEPLISAV BLA
Berkeley, CA -- June 26, 2012 -- Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that the Food and Drug Administration (FDA) has accepted for review the U.S. Biologics License Application (BLA) for HEPLISAV, pursuing an indication for immunization against infection caused by all known subtypes of hepatitis B virus in adults 18 through 70 years of age.
Dynavax President and Chief Medical Officer, Tyler Martin, MD, said, "The FDA has established February 24, 2013, as the PDUFA action date. We look forward to working with the FDA in moving HEPLISAV through the regulatory review process over the next few months."
The company anticipates submitting a European Marketing Authorization Application (MAA) for HEPLISAV in the third quarter of 2012. Upon approval of the HEPLISAV BLA, Dynavax plans to submit a supplemental BLA for an indication in patients with chronic kidney disease.
HEPLISAV is an investigational adult hepatitis B vaccine for which a U.S. BLA has been accepted for review by the FDA and a European Marketing Authorization Application (MAA) is expected to be submitted in the third quarter of 2012. In Phase 3 trials, HEPLISAV demonstrated higher and earlier protection with fewer doses than currently licensed vaccines. Dynavax has worldwide commercial rights to HEPLISAV. HEPLISAV combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist to enhance the immune response.
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious and inflammatory diseases. The Company's lead product candidate is HEPLISAV, a Phase 3 investigational adult hepatitis B vaccine designed to provide higher and earlier protection with fewer doses than currently licensed vaccines. For more information visit www.dynavax.com.
Dynavax Technologies CorporationDynavax Announces FDA Acceptance of HEPLISAV(TM) BLA. Press release. June 26, 2012.