Gilead Files US Application For Bulevirtide In Severe Form Of Viral Hepatitis

Gilead Sciences Inc GILD has submitted a marketing application to FDA for bulevirtide for injection (2 mg) for chronic hepatitis delta virus (HDV) infection in adults with compensated liver disease.
Chronic HDV infection is the most severe form of viral hepatitis.
Bulevirtide has been granted Breakthrough Therapy and Orphan Drug designations by the FDA.
In Europe, Hepcludex (bulevirtide) has been granted Conditional Marketing Authorization and PRIority MEdicines (PRIME) status for chronic HDV infection with compensated liver disease.
Interim results from the Phase 3 MYR301 study indicate that after 24 weeks of therapy, 36.7% of bulevirtide patients achieved the combined virological and biochemical response.
Treatment for 24 weeks with bulevirtide 2 mg had a statistically significant response compared to the no-treatment group.
Additionally, rapid alanine aminotransferase (liver enzymes) reduction and normalization were observed in over 50% of people with HDV in the bulevirtide 2 mg group compared with the no treatment group (5.9%).
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