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FDA requires additional safety data before approving HBV vaccine Heplisav

The FDA will not approve hepatitis B vaccine Heplisav for its proposed indication without further safety data, according to a press release.

The drug (Dynavax) is a recombinant vaccine consisting of hepatitis B surface antigen and a Toll-like receptor 9 agonist developed to increase immune response. The company had sought approval for its use in adult patients aged 18 to 70 years.

In a Complete Response Letter issued to the company, the FDA indicated that the drug could not be approved in such a large patient population without additional evaluation of its safety, and suggested the possibility of more restricted use for Heplisav. The FDA also noted the potential for rare autoimmune events associated with the use of novel adjuvants, and requested clarification regarding quality assurance practices for Heplisav, along with additional process validation data.

The letter follows a meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee held in November 2012, during which members voted 13-1 that the drug had demonstrated efficacy for the prevention of HBV, but the majority (5-8, with one abstention) did not believe that adequate safety data had been presented to support its proposed indication.

According to the release, Dynavax expects to meet with the FDA within 6 weeks to discuss approval for Heplisav.

The FDA will not approve hepatitis B vaccine Heplisav for its proposed indication without further safety data, according to a press release.

The drug (Dynavax) is a recombinant vaccine consisting of hepatitis B surface antigen and a Toll-like receptor 9 agonist developed to increase immune response. The company had sought approval for its use in adult patients aged 18 to 70 years.

In a Complete Response Letter issued to the company, the FDA indicated that the drug could not be approved in such a large patient population without additional evaluation of its safety, and suggested the possibility of more restricted use for Heplisav. The FDA also noted the potential for rare autoimmune events associated with the use of novel adjuvants, and requested clarification regarding quality assurance practices for Heplisav, along with additional process validation data.

The letter follows a meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee held in November 2012, during which members voted 13-1 that the drug had demonstrated efficacy for the prevention of HBV, but the majority (5-8, with one abstention) did not believe that adequate safety data had been presented to support its proposed indication.

According to the release, Dynavax expects to meet with the FDA within 6 weeks to discuss approval for Heplisav.