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Dynavax gives update on Heplisav pre-BLA meeting with FDA
3 February 2012 - US Dynavax Technologies Corp (NASDAQ:DVAX) said on Thursday it met with the US Food and Drug Administration (FDA) in a Pre-Biologics License Application (pre-BLA) meeting, and that they have agreed that the initial HEPLISAV BLA submission will be for an indication in healthy adults 18-70 years of age.
HEPLISAV is an investigational adult hepatitis B vaccine.
The company said that the agreement is a significant expansion of the previously anticipated population of healthy adults age 40 and over. In addition, it was confirmed that a supplemental BLA with an indication for patients with chronic kidney disease will be submitted when the initial BLA is approved.
Dynavax added that it is now conducting the required modifications to the BLA to support the expanded indication and that it intends to file the BLA by the middle of May.
HEPLISAV is an investigational adult hepatitis B vaccine.
The company said that the agreement is a significant expansion of the previously anticipated population of healthy adults age 40 and over. In addition, it was confirmed that a supplemental BLA with an indication for patients with chronic kidney disease will be submitted when the initial BLA is approved.
Dynavax added that it is now conducting the required modifications to the BLA to support the expanded indication and that it intends to file the BLA by the middle of May.
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