FDA grants accelerated approval to Hepcludex, first US treatment for chronic hepatitis delta

The FDA granted accelerated approval to Hepcludex (bulevirtide-gmod) for adults with chronic hepatitis delta virus infection who have no cirrhosis or compensated cirrhosis. It is the first approved treatment for hepatitis delta in the US, a market Gilead estimates at 40,000 to 80,000 people. The approval rests on HDV RNA reduction and ALT normalization, and a boxed warning covers severe flares after stopping treatment.

• Accelerated approval for chronic HDV in adults without cirrhosis or with compensated cirrhosis
• First and only approved HDV treatment in the US, per Gilead
• Approval based on HDV RNA reduction and ALT normalization; clinical outcomes not yet shown
• Boxed warning for severe acute exacerbations after discontinuation