Dynavax reports feedback from FDA meeting regarding Heplisav


Dynavax reported that it concluded a meeting with the FDA regarding its Biologic License Application for HEPLISAV, an investigational adult hepatitis B vaccine. The meeting with FDA resulted in the following messages: The safety database does indeed need additional subjects; VRBPAC's strong endorsement of HEPLISAV's demonstrated immunogenicity was acknowledged; Analyzing the benefit/risk of HEPLISAV's use in discrete patient populations did not fundamentally address the shortfall in the safety database. It was concluded that to do so would unnecessarily restrict the patient population that could benefit from HEPLISAV's approval; The additional safety data collected would facilitate review for an indication in adults 18-70 years of age. Dynavax will meet with the FDA shortly to discuss the protocol for collecting the additional safety data, which is expected to be incorporated into the existing BLA. The company also continues to work on the questions raised by the FDA in the Complete Response Letter regarding the manufacturing and testing of HEPLISAV.

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