Dynavax and Merck & Co., Inc. Update Status of Clinical Hold of Investigational Vaccine HEPLISAV™

17.04.08 - 18:39 ... source : Merck

... Berkeley, CA and Whitehouse Station, NJ, April 17, 2008 - Dynavax Technologies Corporation (Nasdaq:DVAX) and Merck & Co, Inc. announced today the receipt of formal written notification from the US Food and Drug Administration (FDA) detailing a request for information relating to the previously announced clinical hold placed on the two Investigational New Drug Applications for HEPLISAV™, an investigational hepatitis B vaccine being jointly developed by Dynavax and Merck for use in adults and in patients with end stage renal disease. The FDA is requesting a review of clinical and preclinical safety data for HEPLISAV. Additionally, the FDA has requested all available information about the single case of Wegener's granulomatosis reported in the Phase 3 trial. Dynavax and Merck plan to provide a complete response to the FDA query in a timely manner. The FDA will then determine wh ...» Next (HTML)