Heplisav regulatory update

Dynavax said FDA asked for additional subjects to be included in the safety database of adjuvanted HBV vaccine Heplisav to support approval in any indication, nixing the biotech's hopes of seeking approval of the vaccine in a narrowed population. The request came in a meeting to discuss a February complete response letter. According to Dynavax, the agency said the additional safety data would facilitate review for an indication in adults ages 18-70 years, the originally proposed population. Dynavax had hoped to seek approval of the vaccine in a narrower population, including patients with chronic kidney disease (CKD) and adults over 40 years of age, after receiving the complete response letter for use in adults ages 18-70 years (see BioCentury, March 4, 2013). ...