Tuesday, November 27, 2012

Overreaction to FDA - Dynavax' HBV Decision

The Vaccines and Related Biological Products board voted its confidence in the immunogenicity of Dynavax's (DVAX-$2.44) Heplisav by a 13 – 1 vote; however, the committee said in an 8 – 5 decision, with one abstention, that it could not recommend the vaccine for approval to the FDA due to insufficient clinical safety data, especially in certain minority groups.

To ask Dynavax – or any company -- to power the study design specifically tailored to those at minority groups at higher-risk would be cost prohibitive. The biotech has spent more than $300 million (in just the last five years) to move the drug through the pipeline approval process.

If a larger cohort represented by a more diverse ethnic sampling is necessary, how come an under-represented enrollment of blacks (about nine-percent) was sufficient when the FDA positively reviewed GlaxoSmithKline’s (GSK) other adjuvant vaccines, like the Hep-A drug Havrix and the combination DTP-HBV vaccine Infanrix?
Editor David J Phillips does not hold a financial interest in any stocks mentioned in this article. The 10Q Detective has a Full Disclosure Policy.

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