Dynavax Technologies Corp. said March 23 that the safety profile of its experimental hepatitis B vaccine Heplisav was comparable with GlaxoSmithKline’s hepatitis B vaccine Engerix-B, which recently got a regulatory approval.
The company said there was no difference in autoimmune adverse events between subjects vaccinated with Heplisav and Glaxo’s vaccine.
Hepatitis B is a chronic disease, which can lead to cirrhosis of the liver. There is no cure for the condition.
Dynavax is developing Heplisav for populations that are less responsive to current licensed vaccines, including individuals with chronic kidney disease.
In March 2008, U.S. Food and Drug Administration had put a clinical hold on the vaccine and removed that hold in September 2009. Heplisav is in late-stage trials.
Dynavax said the safety data was originally prepared for regulatory submission as part of a documentation that formed the basis upon which Heplisav’s clinical development was allowed to resume in late 2009.
The safety data was originally prepared for submission to the FDA as part of extensive documentation that formed the basis upon which Heplisav’s clinical development was allowed to resume in late 2009.
The total worldwide market for adult hepatitis B vaccines is estimated at more than $500 million annually. Current vaccines leave unmet needs for more rapid and increased protection, particularly for less responsive, underserved populations, the company said.
