Regulatory

FDA rejects Dynavax's adult Hepatitis B vaccine on safety concerns

Last Updated: 2013-02-25 11:45:11 -0400 (Reuters Health)

(Reuters) - U.S. health regulators denied approval for Dynavax Technologies Inc's adult hepatitis B vaccine pending additional data to evaluate its safety.

The U.S. Food and Drug Administration, however, indicated it was willing to have discussions for a more restricted use of the vaccine called Heplisav, Dynavax said.

The company also said the FDA continues to express concern that novel adjuvants that Heplisav contains may cause rare autoimmune events.

Advisors to the U.S. FDA had flagged safety concerns on Heplisav in November, even as they voted unanimously to support the efficacy of the vaccine.

"Furthermore, the FDA requested additional data ... clarifying information on the manufacturing controls and facilities related to the assurance of the quality of the commercial product," Dynavax said in a statement.

The company said it expects to meet with the FDA within six weeks to discuss the steps required for Heplisav's approval.

Dynavax pitched Heplisav for use in patients between 18 and 70 years of age, and the vaccine showed promising efficacy in clinical studies after the administration of just two doses.

GlaxoSmithKline Plc's Engerix B - the most widely used hepatitis vaccine in the world - requires three or four doses in adults.

An estimated 3.5 million to 5.3 million people are living with viral hepatitis in the United States, and vaccination is crucial as it prevents progression of the infection, which is the leading cause of liver cancer.