FDA Approves Gilead Sciences' Hepcludex for Hepatitis D, Offering New Treatment Option
The Food and Drug Administration (FDA) has approved Hepcludex, developed by Gilead Sciences, as the first antiviral therapy for chronic hepatitis D, a severe form of viral hepatitis. This approval marks a significant milestone as it provides a treatment option for a disease that previously had none. Hepcludex works by blocking the receptor used by both hepatitis B and D viruses, thereby reducing viral replication and improving liver health markers. Clinical trials demonstrated that prolonged use of the drug can suppress HDV replication and improve liver inflammation markers, although stopping treatment often leads to relapse. The drug is administered as a subcutaneous injection and was approved under the FDA's Accelerated Approval pathway, which is used for serious diseases with limited treatment options. Gilead's stock rose by about 3% following the announcement. 
