News of the complete response letter (CRL) for bulevirtide, which is already on sale in other markets around the world, including Europe, as Hepcludex, came in remarks by Gilead’s chief medical officer Merdad Parsey in the company’s third-quarter results call.
Parsey said the FDA has concerns about the “manufacture and delivery” of Hepcludex but has not asked for new safety or efficacy clinical trials of the drug. “We plan to resubmit as quickly as possible, and we’ll work with the agency on the path forward,” he added.
