Agency does not favor development in healthy adults but is considering evaluation in renal failure patients.
FDA has told Dynavax Technologies and Merck & Co. that the clinical hold on Heplisav, an HBV vaccine, still stands and has asked for additional safety data. FDA noted that the risk versus benefit profile of Heplisav is not favorable to further clinical development among healthy adults.
The agency did, however, suggest that Heplisav may be more beneficial in patients with renal failure. FDA has requested more information before considering further pursuit of clinical studies in such a setting.
Merck and Dynavax are developing this vaccine under a $136 million alliance. In March the FDA placed a clinical hold on the two IND applications for Heplisav after a case of Wegener’s granulomatosis was reported in a Phase III trial in adults.