Posted by Michael Wonder on 19 Jun 2017
Gilead receives approval in Canada for Vemlidy (tenofovir alafenamide) for the treatment of chronic hepatitis B virus infection
19 June 2017 - Vemlidy is a once-daily treatment that demonstrated similar efficacy with improved renal and bone laboratory safety parameters compared to Viread,
Gilead Sciences today announced that Health Canada has granted a Notice of Compliance for Vemlidy 25 mg tablets, a once-daily treatment for adults with chronic hepatitis B virus (HBV) infection with compensated liver disease.
The approval of Vemlidy is supported by 48-week data from two international Phase 3 studies (Studies 108 and 110) among 1,298 treatment-naïve and treatment-experienced adult patients with chronic HBV infection. Study 108 randomised and treated 425 HBeAg-negative patients with either Vemlidy or Viread, and Study 110 randomised and treated 873 HBeAg-positive patients with either Vemlidy or Viread. Both studies met their primary endpoint of non-inferiority to Viread based on the percentage of patients with chronic hepatitis B with plasma HBV DNA levels below 29 IU/mL at 48 weeks of therapy.
