FDA gives update on HEPLISAV clinical hold

The US Food and Drug Administration has sent an update to the Dynavax Technologies Corp and Merck & Co on the clinical hold (Marketletter March 31) placed on their investigational vaccine HEPLISAV (hepatitis B surface antigen and oligonucleotide).

The FDA is requesting a review of clinical and preclinical safety data on the two new investigational applications of the drug, as well as as all available information on the single case of Wegener's granulomatosis reported during the Phase III trial.

Dynavax and Merck have promised a timely response to the FDA's request. Only one case of Wegener's has occured during the trials and it is hoped that, once the FDA have validated the treatment's safety, the study may continue.