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

• Gilead Sciences Inc (NASDAQ: 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%).

• Price Action: GILD shares are up 0.89% at $68.39 during the market session on the last check Friday.

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