Gilead wins EU nod for full approval of hepatitis delta virus therapy
Justin Sullivan
- Gilead (NASDAQ:GILD) announced Thursday that an expert panel of the European Medicines Agency (EMA) recommended a full market authorization for its antiviral Hepcludex (bulevirtide) as a treatment for adults with chronic hepatitis delta virus and compensated liver disease.
- If the so-called positive opinion of the EMA’s Committee for Medicinal Products for Human Use (CHMP) is adopted by the European Union (EU), Hepcludex will become the only approved HDV treatment in the region, Gilead (GILD) added.
- The decision is based on week-48 data from the company’s pivotal Phase 3 MYR301 trial, which evaluated the safety and efficacy of bulevirtide as a treatment for HDV.
- In 2020, the EU regulators granted conditional marketing authorization for the treatment, and the company says it continues to engage with the FDA to bring bulevirtide to U.S. patients living with HDV.