Data From Two Phase 3 Studies Demonstrate HEPLISAV's Superiority in Immunizing Persons With Diabetes From Hepatitis B
Also today, the
At the annual meeting of the
Of the 218 subjects with diabetes in the MITT population (179 HEPLISAV; 39 Engerix-B), the seroprotection rates (SPRs) for HEPLISAV were superior to Engerix-B at Weeks 8 through 52.
- At the pre-specified primary comparison time points of Week 12 for HEPLISAV and Week 32 for Engerix-B, the SPR was 79% in the HEPLISAV group and 61% in the Engerix-B group.
- At Week 12, the SPR was 79% in the HEPLISAV group and 11% in the Engerix-B group.
- At Week 52, the SPR was 82% in the HEPLISAV group and 54% in the Engerix-B group.
Last year, in a late-breaker oral presentation on
- At 12 weeks, 84 percent of adult with diabetes who received HEPLISAV achieved seroprotection as compared to 0 percent of adult diabetics who received Engerix-B.
- At Week 28, 93% of subjects in the HEPLISAV group versus 35% in the Engerix-B group achieved seroprotection.
Today's vote to recommend hepatitis B vaccine should be administered to unvaccinated adults with diabetes who are less than 60 years of age reflects the ACIP conclusion after a multi-year analysis on the need for preventing hepatitis B infection in diabetics. According to the CDC, there are at least 18 million people diagnosed with diabetes in
The ACIP is an advisory body to the CDC that provides advice and guidance regarding control of vaccine-preventable diseases in
HEPLISAV is an investigational adult hepatitis B vaccine. In earlier Phase 3 trials, HEPLISAV demonstrated increased, rapid protection with fewer doses than current licensed vaccines.
This press release contains "forward-looking statements," including the potential role of HEPLISAV, diabetes diagnoses forecasts and our plans to present at an Analyst and Investor Day, that are subject to a number of risks and uncertainties. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including whether the recommendations will be approved by the Director of CDC and the
Engerix-B® is a registered trademark of GlaxoSmithKline
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