FDA asks for postmarketing details, delays Heplisav-B PDUFA

Dynavax Technologies Corp. (NASDAQ:DVAX) said FDA requested additional information regarding the company's proposed postmarketing study for its HBV vaccine Heplisav-B, echoing requests from panel members during last week’s meeting of FDA’s Vaccines and Related Biological Products Advisory Committee.

The agency asked Dynavax to provide details on the study’s timelines, measures to control biases between study arms, and an updated statistical analysis plan. The company said its response will trigger a major amendment to the BLA, delaying its PDUFA date by up to three months beyond the original Aug. 10 date. Dynavax said the updated timing does not impact the company's plans to launch the vaccine in the U.S. in early 2018...