Game-changing hep B vaccine gets FDA nod

The first 2-dose hepatitis B vaccine, which was recently approved by FDA, is expected to be commercially available in early 2018.

Dynavax Technologies’ Heplisav-B (Hepatitis B Vaccine, Recombinant (Adjuvanted) is for prevention of infection caused by all known subtypes of hepatitis B virus in adults aged 18 years and older.

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As the first new hepatitis B vaccine in the United States in more than 25 years, Heplisav-B will compete with Engerix-B (GlaxoSmithKline), a 3-dose hepatitis B vaccine.

While Engerix-B currently dominates the market, Heplisav-B has the potential to become the next standard of care and could reach peak sales of about $600 million in the US, according to Katherine Xu, an analyst for William Blair.

“The 2-dose vaccine…is really a game changer,” Xu told Reuters.

There is a huge market for the vaccine since, in 2015, new cases of acute hepatitis B increased by more than 20% nationally.

"Prevention of hepatitis B in adults through vaccination is more important than ever given the increase in the rate of infections," said William Schaffner, MD, professor of preventive medicine at Vanderbilt University Medical Center, in a statement from Dynavax. “A 2-dose schedule with higher rates of protection, along with other strategies, may help us move closer to the goal of eliminating hepatitis B as a public health problem in the United States.”

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The approval of Heplisav-B was based on data from three, phase 3 non-inferiority trials of nearly 10,000 adult participants who received Heplisav-B. Results from the largest phase 3 trial, which included 6,665 participants, showed that Heplisav-B demonstrated a statistically significantly higher rate of protection of 95% compared with 81% for Engerix-B, according to Dynavax.

In a subgroup analysis of 961 participants with type 2 diabetes, Heplisav-B showed a statistically significantly higher rate of protection of 90% compared to 65% for Engerix-B.

Dynavax expects to commercially launch the vaccine in the United States in the first quarter of 2018. In preparation for launch, Dynavax has been building commercial infrastructure and optimizing manufacturing processes to meet anticipated demand, according to the manufacturer.

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