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[TwoNE1]

DVAX: Dynavax Announces FDA Approval of HEPLISAV-B(TM) for Prevention of Hepatitis B in Adults

BERKELEY, CA--(Marketwired - November 09, 2017) - Dynavax Technologies Corporation (DVAX) today announced that the U.S. Food and Drug Administration (FDA) has approved HEPLISAV-B [Hepatitis B Vaccine, Recombinant (Adjuvanted)] for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. HEPLISAV-B is the first new hepatitis B vaccine in the United States in more than 25 years and the only two-dose hepatitis B vaccine for adults.
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Dynavax expects to commercially launch HEPLISAV-B in the United States in the first quarter of 2018. In preparation for launch, Dynavax has been building commercial infrastructure and optimizing manufacturing processes to meet anticipated demand.
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Conference Call Details
The Dynavax management team will host a conference call and webcast today, Thursday, November 9, 2017 at 5:00 p.m. Eastern Time, to provide more information about the FDA approval of HEPLISAV-B. The live call can be accessed by phone by dialing [phone] from the U.S. and Canada or [phone] internationally and using the passcode 5357789. The live call is being webcast and can be accessed in the "Investors and Media" section of the Company's website at www.dynavax.com. A replay of the webcast will be available for 30 days following the live event.
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Important Safety Information (ISI)
Do not administer HEPLISAV-B to individuals with a history of severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast.

Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV-B.

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to HEPLISAV-B.

Hepatitis B has a long incubation period. HEPLISAV-B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration.

The most common patient reported adverse reactions reported within 7 days of vaccination were injection site pain (23% to 39%), fatigue (11% to 17%) and headache (8% to 17%).

source: https://finance.yahoo.com/news/dynavax-announces-fda-approval-heplisav-214519448.html