Pharmaprojects R&D Pipeline News Feed
Heplisav shows unfavourable risk benefit profile in healthy subjects
22nd October 2008
The US FDA has advised that further clinical evaluation of Heplisav, a hepatitis-B vaccine, is no longer warranted in healthy adults and children due to an unacceptable risk benefit balance. Phase III trials of the vaccine were put on hold by the FDA in March this year following a single case of Wegner's granulomatosis, a rare disorder characterised by chronic tissue inflammation and the formation of granuloma in the nasal passages, lungs and kidneys. Heplisav, which is under joint development by Dynavax and Merck & Co, may have still potential in patients with renal failure; however, the FDA has requested additional information from the companies before further trials take place. Dynavax and Merck will evaluate the data before deciding whether to pursue development in this patient population.
Merck & Co also has a V232 hepatitis-B vaccine currently in Phase III trials in renal predialysis and dialysis patients.
