Bulevirtide has been granted breakthrough therapy and orphan drug designations by the FDA.
Gilead Sciences has submitted a biologics license application (BLA) to the FDA for bulevirtide for injection, a potential first-in-class antiviral medicine for the treatment of chronic hepatitis delta virus (HDV) infection in adults. Bulevirtide has been granted breakthrough therapy and orphan drug designations by the FDA.
The submission is supported by data from completed and ongoing phase 2 studies and the ongoing phase 3 MYR301 study, which supports the safety and efficacy of bulevirtide once daily after 24 weeks of therapy.
Interim results from the phase 3 MYR301 study indicate that after 24 weeks of therapy, the proportion of people with HDV infection achieving the combined virological and biochemical response was 36.7% with bulevirtide 2 mg, 28% in participants receiving bulevirtide 10 mg and 0% in participants currently under observation who have not received antiviral treatment at this stage of the study.
In Europe, Hepcludex (bulevirtide) has been granted conditional marketing authorization by the European Commission and PRIority MEdicines (PRIME) scheme eligibility by the European Medicines Agency, as the first approved treatment in Europe for adults with chronic HDV infection with compensated liver disease.