CHMP Recommends Full Marketing Authorization For Gilead's Hepcludex To Treat Hepatitis Delta Virus

(RTTNews) - Gilead Sciences, Inc. (GILD) Thursday said it has received positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommending full Marketing Authorisation for Hepcludex for the treatment of adults with chronic HDV, the most severe form of viral hepatitis, and compensated liver disease.

The positive opinion from the CHMP is based on the Phase 3 MYR301 study showing efficacy and safety of Hepcludex.

If the European Commission grants, Hepcludex will be the only approved treatment for HDV in the EU, the company said.