Dynavax Technologies Corporation announced receipt of communication from the US Food and Drug Administration (FDA) regarding the clinical hold on the two Heplisav Investigational New Drug (IND) Applications, for healthy adults and patients with end-stage renal disease (ESRD).
In this communication, the FDA has requested additional clinical and safety information which the agency indicated may be helpful in its risk assessment of the two INDs and may assist in finding a development path forward for Heplisav hepatitis B vaccine, not only in ESRD patients but also in healthy adults.
This communication followed a Clinical Hold Oversight Meeting held at the FDA on January 8, 2009. Dynavax believes the information requested by the FDA is available and intends to provide this to the agency in the near future.
Since March 2008, the two INDs for Heplisav have been and remain on clinical hold by the FDA in the United States.
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops a diversified, well-funded pipeline of novel Toll-like Receptor (TLR) product candidates.