Posted by Michael Wonder on 19 Nov 2024
FDA grants breakthrough therapy designation to Huahui Health's libevitug (HH-003) for treatment of chronic hepatitis D virus infection
18 November 2024 - Huahui Health today announced that its investigational hepatitis D and B drug candidate, Libevitug (HH-003), an anti-preS1 human monoclonal antibody, received breakthrough therapy designation from the US FDA for the treatment of patients with chronic hepatitis delta virus infection.
The breakthrough therapy designation is based on the clinical results from two independent clinical trials in subjects with chronic hepatitis D virus infection, HH003-20 and HH003-204.
