Shots:
- The US FDA has granted accelerated approval for Gilead’s Hepcludex (bulevirtide-gmod; 8.5mg) for the treatment of adults with chronic HDV infection
- Approval was based on the P-III (MYR301) trial assessing Hepcludex (QD, SC) for 144wks. in pts living with HDV, followed by 96wks. of off-treatment follow-up
- Trial showed significant improvements in HDV RNA reduction & ALT normalization vs delayed treatment at Wk. 48, while confirmatory trials remain ongoing to verify clinical benefit
Ref: Businesswire | Image: Gilead | Press Release
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