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Dynavax receives FDA green light for hepatitis B vaccine

Heplisav-B becomes first and only two-dose hep B vaccine approved in the US

DynavaxDynavax is celebrating some positive news after it received a US marketing licence for its hepatitis B prevention vaccine, its first FDA-approved product.

The injectable becomes the first two-dose vaccine approved in the US for this indication is also the first new injection for hepatitis-B after a 25-year-long approval drought.

Eddie Gray, chief executive officer, Dynavax, said: “We expect that [Heplisav -B] will become an essential tool in the public health community’s fight to prevent hepatitis B, and we look forward to making Heplisav-B available to clinicians and their adult patients.”

Hepatitis B is a viral disease of the liver that can become chronic and lead to cirrhosis, liver cancer and death. Approximately 20 million people in the US have the virus with 1.5 million diagnosed each year.

Current hepatitis B vaccines requires three shots over a six-month period, but almost half of adults fail to complete the series within one year, according to the American Journal of Public Health.

Gray added: “Heplisav-B is the first FDA-approved product for Dynavax and demonstrates our ability to develop innovative products and progress them from discovery to commercialisation.”

The US Food and Drug Administration’s (FDA) approval was based on the back of data from phase III, non-inferiority trials, which showed that the vaccine demonstrated a significantly higher rate of protection of 95% compared with 81% for GlaxoSmithKline’s Engerix-B, the current standard of therapy.

In a subgroup analysis of 961 participants with type 2 diabetes, Heplisav-B demonstrated a statistically significant higher rate of protecting (90%) compared to Engerix-B (65%).

Dynavax expects to launch its vaccine in the US in the first quarter of 2018.

Article by
Gemma Jones

13th November 2017

From: Regulatory



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