Dynavax and Merck announced that their hepatitis B vaccine Heplisav achieved the primary endpoint in a Phase III study. In the study, 95.1 percent of subjects who received Heplisav developed protective antibodies to hepatitis B versus 81.1 percent of subjects who received Engerix-B, a marketed drug. Heplisav is being developed for patients with end-stage renal disease.
Back in April the FDA put a clinical hold on the drug's development because one subject was suspected to have Wegener's granulomatosis, an rare inflammation of blood vessels. The hold is still in effect, and the FDA has requested a review of clinical and preclinical safety data along with all available information about the Wegener's granulomatosis case.
- here's the release