The U.S. Food and Drug Administration recently told biopharmaceutical company Dynavax that more safety data is necessary before the agency can approve its hepatitis B vaccine.
Hepatitis B is caused by the hepatitis B virus, which is transmitted through blood or other body fluids. It can be passed by sharing needles or through sexual intercourse, according to the U.S. Centers for Disease Control and Prevention. There are currently vaccines available to help prevent the infection.
FDA denies Heplisav
Dynavax's Biologic License Application for the hepatitis B vaccine, Heplisav, was denied by the FDA for a lack of diverse subjects. The agency noted that, while the Vaccines and Related Biological Products Advisory Committee endorses Heplisav, clinical testing's safety data did not account for potential shortfalls. The company analyzed the benefits and risks of the vaccine in discrete patient populations, which would unnecessarily restrict the amount of patients who would be able to benefit from the drug.
"We are encouraged by the supportive feedback received from the FDA and appreciate the informative interactions and clarity provided regarding Heplisav's path toward approval in the broader indication," said Eddie Gray, CEO of Dynavax.
The company anticipates another meeting with the FDA to discuss the protocol for further data collection, which will be included into a revised BLA. They will be including subjects ages 18 to 70 in their new safety data.
Dynavax manufactures Heplisav at their facilities in Germany. The company seeks to eliminate drawbacks of the existing hepatitis B vaccines with the new drug, such as the slow onset of results, more effective protection and poor patient compliance. Heplisav was shown to have earlier protection with fewer doses than current vaccinations in Phase 3 trials.