FDA Approves 2-Dose Hepatitis B Vaccine, Heplisav-B

William Schaffner, MD

After clearing multiple hurdles on its way to a decision, Heplisav-B, the only 2-dose Hepatitis B (HBV) vaccine recombinant in the United States, was approved by the US Food and Drug Administration (FDA) for the prevention of infection caused by all known subtypes of HBV.

The Dynavax product is the first new HBV to be approved in the US in more than a quarter-century, and the first HBV vaccine to utilize a 2-dose regimen compared to the traditional 3-dose regimen, which almost half of adults fail to complete within 1 year despite a 6-month dosing period. The condition has no cure and the rate of new cases increased by more than 20% nationally in 2015.

The FDA’s decision was originally expected to come August 10 but was delayed, as the agency had requested more data on the safety studies done by Dynavax for the product. The FDA’s Vaccines and Related Biological Products Advisory Committee did, however, vote 12-1 in favor of the vaccine’s licensure safety data the month prior. Since submitting its biologic license application (BLA) in 2012, Dynavax has undergone multiple advisory meetings and delays.

"Prevention of hepatitis B in adults through vaccination is more important than ever given the increase in the rate of infections," William Schaffner, MD, a professor of preventive medicine at Vanderbilt University Medical Center, said in a statement. "Too many at-risk adults remain unprotected against this virus. A two-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."

Approval came based on data from 3 phase 3 non-inferiority trials that included more than 10,000 patients. The studies investigated the drug compared to Engerix-B, administered in the standard 3-dose regimen over 6 months.

The largest of the 3 trials showed statistical significance from Heplisav-B, with the drug providing a 95% rate of protection compared to 81% with Engerix-B. In sub-analysis involving patients with type 2 diabetes, the drug’s protection rate was revealed to be 90% compared to 65% with Engerix-B.

"HEPLISAV-B is the first FDA-approved product for Dynavax and demonstrates our ability to develop innovative products and progress them from discovery to commercialization," Eddie Gray, the chief executive officer of Dynavax, said in a statement. "We would like to thank the many study participants and clinical trial investigators who contributed to the development of HEPLISAV-B. We expect that it 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."

The most common local reaction across all 3 trials was injection site pain, experienced by 23% to 39% of patients, while the most common reactions were fatigue (11% to 17%) and headache (8% to 17%).

Heplisav-B is expected to hit the market by the first quarter of 2018, according to Dynavax. The company is reportedly preparing to meet demand by "building commercial infrastructure and optimizing manufacturing processes."

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