DOW JONES NEWSWIRES
Dynavax Technologies Corp. (NASDAQ-NMS:DVAX) (DVAX) and Merck & Co. (NYSE:MRK) (MRK) said the Food and Drug Administration placed a clinical hold on the two investigational new drug applications for HEPLISAV, a hepatitis B vaccine under joint development, after a subject was diagnosed with Wegener's granulomatosis.
The hold after a serious adverse event occurred in one subject who received the drug in a phase III study conducted outside the U.S., the companies said. The subject was preliminary diagnosed as having Wegener's granulomatosis, a rare disease in which the blood vessels are inflamed.
All subjects in the phase III study have received all doses as per the study protocol and will continue to be monitored.
Dynavax (NASDAQ-NMS:DVAX) and Merck (NYSE:MRK) said about 2,500 people were vaccinated with more than 5,000 doses of HEPLISAV in 10 trials over the last seven years without any prior reports of Wegener's granulomatosis.
Investigators are looking into whether the disease was a preexisting condition or was related to the administration of the vaccine.
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(END) Dow Jones Newswires 03-17-08 1630 Copyright (c) 2008 Dow Jones & Company, Inc.