FDA rejects approval of hepatitis B vaccine
The US FDA has rejected Dynaxax Technologies’ Biologic License Application for its investigational adult hepatitis B vaccine, Heplisav. The company received a Complete Response Letter (CRL) from the regulatory body, requesting additional data from Dynavax’s process validation program and clarifying information on the manufacturing controls and facilities related to the assurance of the quality of the commercial product.
In the CRL, the FDA specified that the indication in adults 18-70 years of age could not be approved without further evaluation of safety in this broad age group. The FDA also continues to express concern that novel adjuvants may cause rare autoimmune events.
Dynavax and the FDA plan to discuss the CRL and continue discussions regarding a more restricted use of Heplisav, particularly in those adult patients who may receive the greatest benefit. They will then discuss the fastest route to approval for these patients.
The FDA accepted Dynavax’s Biologic License Application in June 2012. In November 2012, the FDA’s Vaccines and Related Biological Products Advisory Committee voted 8 to 5 with 1 abstention that there was insufficient data to adequately support the safety of Heplisav, although the Committee voted 13 to 1 that Heplisav data adequately demonstrated immunogenicity.
Approximately 3.5 million to 5.3 million people are living with viral hepatitis in the United States. Vaccination is crucial because it prevents progression of the infection, which is the leading cause of liver cancer.
Dynavax’s Marketing Authorization Application also continues to be under review in Europe.
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