World News: 12:00 GMT Tuesday 3rd December 2019. [Dynavax Technologies Corporation via Globe Newswire via SPi World News]
EMERYVILLE, Calif. , Dec. 03, 2019 (GLOBE NEWSWIRE) -- (NASDAQ: DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, today announced that it has filed a report on a cumulative analysis (comprising both required interim analyses) of its post-marketing study of ® [Hepatitis B Vaccine (Recombinant), Adjuvanted] for review by the U.S. Food and Drug Administration (FDA). The study is assessing the rates of occurrence of acute myocardial infarction (AMI) in persons receiving HEPLISAV-B compared with Engerix-B. The interim report assesses unadjudicated events of AMI. The event rates in this interim analysis were similar between the two treatment arms. The independent data monitoring committee (DMC) concurred this analysis showed no evidence of an increase in AMI events in the HEPLISAV-B arm. The study was initiated in August 2018 and will continue through November 2020. Final study results will be reported upon study completion.
“These results reinforce our previous clinical data regarding the safety of HEPLISAV-B and support our confidence that HEPLISAV-B can be the emerging standard of care for preventing hepatitis B infection in adults,” commented , MD, Chief Medical Officer. “We are pleased to collaborate with for their rigorous conduct of this study, and look forward to a scientific presentation of the final data at an appropriate forum in the future.”
The study, “Post-Marketing Observational Study to Evaluate the Occurrence of Acute Myocardial Infarction in Adults 18 Years of Age and Older Who Receive HEPLISAV-B Compared with Another Hepatitis B Vaccine,” is a post-marketing requirement related to FDA approval of HEPLISAV-B on November 9, 2017. Dynavax previously announced the complete accrual of more than 30,000 patients who received HEPLISAV-B and more than 30,000 patients who received Engerix-B in the ongoing post-marketing study.
In adults, hepatitis B is spread through contact with infected blood and through unprotected sex with an infected person. The CDC recommends vaccination for those at high risk for infection due to their jobs, lifestyle, living situations and travel to certain areas. Because people with diabetes are particularly vulnerable to infection, the CDC recommends vaccination for adults age 19 to 59 years with diabetes as soon as possible after their diagnosis, and for people age 60 years and older with diabetes at their physician's discretion. Approximately 20 million U.S. adults have diabetes and 1.5 million new cases of diabetes are diagnosed each year.
For more information about HEPLISAV-B, visit .
Derek Cole, President Investor Relations Advisory Solutions
Globe Newswire: 12:00 GMT Tuesday 3rd December 2019
SPi News is published by Sector Publishing Intelligence Ltd.
© Sector Publishing Intelligence Ltd 2019. [Admin Only]
Sector Publishing Intelligence Ltd.
Agriculture House, Acland Road, DORCHESTER, Dorset DT1 1EF United Kingdom
Registered in England and Wales number 07519380.