Twice a month vaccination… high serum defense rate
The European Commission has approved the marketing of Heplisav B, a hepatitis B vaccine from US biopharmaceutical company Dynavax Technologies Corporation.
DynaVax announced on the 19th (local time) that the European Commission has decided to market the Heprisab B vaccine for active immunization against hepatitis B by all known hepatitis B virus subtypes in adults over 18 years of age.
This approval is in response to the positive comments of the European Medicines Agency (EMA) Drug User Advisory Committee (CHMP) on the application for marketing authorization from DynaVax.
The approval and recommendations of CHMP are based on the positive benefit-risk of Heplisab B, as demonstrated by the safety and immunogenicity results from three phase 3 clinical trials.
“Hepatitis B is a highly contagious and deadly virus. The infection rate is increasing, and it is estimated that more than 250 million people are infected worldwide. Fortunately, it can be prevented through effective vaccinations.”
“Heprisab B has a higher level than the conventional vaccine (Engerix-B)’s three-dose regimen through a statistically significantly higher serum protection rate observed in a direct comparison clinical trial with a two-dose regimen that can be completed in one month. It provides a unique opportunity to address known problems with compliance while providing a preventive effect. We are happy to have the Heprisab B approved, and we look forward to launching it in Europe this year.”
The marketing authorization of the European Commission is valid in all European Union member states and in Norway, Iceland and Liechtenstein, which are members of the European Free Trade Association (EFTA). Heprisab B was approved by the U.S. Food and Drug Administration (FDA) in 2017.
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