The World Health Organization describes Hepatitis B as a serious viral infection of the liver that, if not promptly addressed, can be fatal, and kills over 600,000 people every year — most especially in developing countries. While there is a vaccine for this disease, there is no guaranteed cure.
Yesterday, Dynavax Technologies Corporation, a multinational biopharmaceutical company that specializes in the research and development of products that address inflammatory and infectious diseases, announced that it is canceling its European Marketing Authorization Application or MAA for their lead product candidate, Heplisav, a Phase 3 hepatitis B vaccine for adults.
Find out more about Hepatitis B.
The European Medicines Agency (EMA) issued a standard 180-day deadline for Dynavax to correct any of their application’s issues after European regulators noted that Heplisav’s safety database was not enough to eliminate uncommon adverse effects. The company declared the 180 days would not be enough time to allow them to gather more clinical findings and effectively withdrew their product from the agency’s review.
Dynavax announced that it will soon be conducting a supplementary Heplisav clinical study involving the participation of 8,000 patients, called HBV-23, for the purpose of expanding the drug’s safety database according to regulatory standards for licensure.
While this announcement is indeed a setback for those suffering with Hepatitis B, there has still been a great deal of success in research and development of Hepatitis B vaccines, treatments, and an eventual cure. BioNews Texas outlined an article in the spring of 2013 on how The Texas Biomedical Research Center was instrumental in researching and developing a Hepatitis B vaccine, and continues to work toward a cure as well. While news of treatment setbacks are discouraging, time and time again, setbacks such as these prove to be necessary pivots for drug developers to eventually develop successful therapies that are both safe and effective for patients.