EMA panel adopts positive opinion of Vemlidy for treatment of HBV in adults, adolescents

Gilead Sciences Inc. announced that the EMA’s scientific committee — Committee for Medicinal Products for Human Use — has adopted a positive opinion on its Marketing Authorization Application for Vemlidy for the treatment of chronic hepatitis B virus infection in adults and adolescents aged 12 years and older.

The positive opinion includes recommendation of 25 mg of Vemlidy (tenofovir alafenamide, Gilead Sciences; TAF) — a nucleoside analog reverse transcriptase inhibitor — in treatment-naive and treatment-experienced adults and adolescents with chronic HBV who are positive or negative for hepatitis B e antigen. The CHMP’s recommendation will be addressed by the European Commission, which has the authority to approve the drug for the European Union.

TAF is a prodrug of tenofovir that has demonstrated similar efficacy rates at a dose less than one-tenth that of Gilead’s other antiviral for HBV, Viread (tenofovir disoproxil fumarate, Gilead Sciences; TDF), which is given at 245 mg, according to the release. Clinical data showed TAF improved renal and bone laboratory safety parameters compared with tenofovir disoproxil fumarate.

The marketing application is based on data from two international phase 3 clinical studies, where 1,298 treatment-naive and treatment-experienced adult patients with chronic HBV were randomly assigned either TAF or TDF. Both studies met their primary endpoint of noninferiority to TDF based on the percentage of patients with chronic HBV with plasma HBV DNA levels below 29 IU/mL at 48 weeks of therapy, according to Gilead.

The FDA approved the use of TAF for chronic HBV last week.