Drug/Device Pipeline

FDA Approves HBV Vaccine Heplisav-B for Adults

Dynavax announced that the FDA approved Heplisav-B, a recombinant hepatitis B vaccine, for all known subtypes of HBV in adults aged 18 years or older, according to a press release.

William Schaffner, MD
William Schaffner
Robert Janssen, MD
Robert Janssen

“Once physicians and public health institutions become aware of Heplisav-B, it will be an attractive option to use for all those individuals who are indicated to receive hepatitis B vaccines as adults who haven’t been vaccinated as children,” William Schaffner, MD, professor of preventive medicine at the Vanderbilt University Medical Center, and a public health advisor during Dynavax’s presentations to the FDA, told Healio.com/Hepatology. “Given the performance characteristics of the vaccine, I think it will restimulate people to actually go after those patients more vigorously.”

Heplisav-B is a combination of HBV surface antigen with Dynavax’s proprietary Toll-like receptor 9 (TLR9) agonist, designed to enhance immune response. The treatment consists of two doses, with the second dose provided at 1 month.

“I think what’s remarkable about Heplisav is that it’s the first new hepatitis B vaccine in 25 years,” Robert Janssen, MD, chief medical officer of Dynavax, told Healio.com/Hepatology. “Really, the most important thing is that two doses of Heplisav induces significantly higher and earlier seroprotection rates than three doses of the other approved vaccines. I think this is important in a time when we’re seeing increases in hepatitis B transmissions in the United States.”

The vaccine’s approval was based on data from three phase 3 noninferiority trials of approximately 10,000 adult patients with HBV who received Heplisav-B.

In the largest phase 3 trial, which included 6,665 patients, Heplisav-B demonstrated a significantly higher rate of protection compared with GSK Source’s Engerix-B (95% vs. 81%). Similarly, in a subgroup analysis of 961 patients with type 2 diabetes, Heplisav-B resulted in a significantly higher rate of protection compared with Engerix-B (90% vs. 65%).

The most common local reaction throughout the phase 3 trials was injection site pain (23% to 39%), and the most common systemic reactions included fatigue (11% to 17%) and headache (8% to 17%).

According to Schaffner, although there are HBV vaccines that work effectively in infants, children and adolescents — with protection rates of over 90% — the protection rates of those vaccines are between 40% and 70% in adults. Schaffner noted that the three-dose process of other vaccines over 6 months can often lead to patients not completing the series and leaves patients at risk until the series is complete.

“What we saw in all the groups we looked at, we saw significantly higher rates of protection in the Heplisav group but particularly in those groups who don’t respond to the other vaccines,” Janssen said in reference to specific populations that often have lower rates of success with the other vaccines, including older patients, those with diabetes, those with obesity and those who smoke.

“For hepatitis B, we now have three very effective vaccines that can be used in populations,” Schaffner concluded. “I think if we can get our acts together and get much more aggressive and comprehensive in the delivery of those vaccines, use them all to good effect in the populations indicated, we can reverse that increase in rates of hepatitis B in this country and drive hepatitis B rates down much further.”

Dynavax expects to commercially launch Heplisav-B in the U.S. during the first quarter of 2018. – by Talitha Bennett

Reference: www.dynavax.com

Disclosures: Schaffner reports no relevant financial disclosures. Janssen reports he is an employee of Dynavax.

Dynavax announced that the FDA approved Heplisav-B, a recombinant hepatitis B vaccine, for all known subtypes of HBV in adults aged 18 years or older, according to a press release.

William Schaffner, MD
William Schaffner
Robert Janssen, MD
Robert Janssen

“Once physicians and public health institutions become aware of Heplisav-B, it will be an attractive option to use for all those individuals who are indicated to receive hepatitis B vaccines as adults who haven’t been vaccinated as children,” William Schaffner, MD, professor of preventive medicine at the Vanderbilt University Medical Center, and a public health advisor during Dynavax’s presentations to the FDA, told Healio.com/Hepatology. “Given the performance characteristics of the vaccine, I think it will restimulate people to actually go after those patients more vigorously.”

Heplisav-B is a combination of HBV surface antigen with Dynavax’s proprietary Toll-like receptor 9 (TLR9) agonist, designed to enhance immune response. The treatment consists of two doses, with the second dose provided at 1 month.

“I think what’s remarkable about Heplisav is that it’s the first new hepatitis B vaccine in 25 years,” Robert Janssen, MD, chief medical officer of Dynavax, told Healio.com/Hepatology. “Really, the most important thing is that two doses of Heplisav induces significantly higher and earlier seroprotection rates than three doses of the other approved vaccines. I think this is important in a time when we’re seeing increases in hepatitis B transmissions in the United States.”

The vaccine’s approval was based on data from three phase 3 noninferiority trials of approximately 10,000 adult patients with HBV who received Heplisav-B.

In the largest phase 3 trial, which included 6,665 patients, Heplisav-B demonstrated a significantly higher rate of protection compared with GSK Source’s Engerix-B (95% vs. 81%). Similarly, in a subgroup analysis of 961 patients with type 2 diabetes, Heplisav-B resulted in a significantly higher rate of protection compared with Engerix-B (90% vs. 65%).

The most common local reaction throughout the phase 3 trials was injection site pain (23% to 39%), and the most common systemic reactions included fatigue (11% to 17%) and headache (8% to 17%).

According to Schaffner, although there are HBV vaccines that work effectively in infants, children and adolescents — with protection rates of over 90% — the protection rates of those vaccines are between 40% and 70% in adults. Schaffner noted that the three-dose process of other vaccines over 6 months can often lead to patients not completing the series and leaves patients at risk until the series is complete.

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“What we saw in all the groups we looked at, we saw significantly higher rates of protection in the Heplisav group but particularly in those groups who don’t respond to the other vaccines,” Janssen said in reference to specific populations that often have lower rates of success with the other vaccines, including older patients, those with diabetes, those with obesity and those who smoke.

“For hepatitis B, we now have three very effective vaccines that can be used in populations,” Schaffner concluded. “I think if we can get our acts together and get much more aggressive and comprehensive in the delivery of those vaccines, use them all to good effect in the populations indicated, we can reverse that increase in rates of hepatitis B in this country and drive hepatitis B rates down much further.”

Dynavax expects to commercially launch Heplisav-B in the U.S. during the first quarter of 2018. – by Talitha Bennett

Reference: www.dynavax.com

Disclosures: Schaffner reports no relevant financial disclosures. Janssen reports he is an employee of Dynavax.