Gilead Leads Drug Approval NewsBy
A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from Gilead.
Editor’s Note: This article is updated on a continuous basis for news announced from Wednesday January 11, 2017 to Tuesday January 17, 2017.
EC OKs Gilead’s Hep B Drug
The European Commission has granted marketing authorization for Gilead Sciences’ Vemlidy (tenofovir alafenamide, TAF) 25 mg, for treating chronic hepatitis B virus (HBV) infection. The marketing authorization allows for the marketing of TAF in the 28 countries of the European Union and in Norway and Iceland.
TAF is a targeted prodrug of tenofovir that has demonstrated antiviral efficacy similar to Gilead’s Viread (tenofovir disoproxil fumarate, TDF) 245 mg, but at one-tenth the dose. Vemlidy was approved by the US Food and Drug Administration in November 2016 for treating chronic HBV infection in adults with compensated liver disease, and by the Japanese Ministry of Health, Labor and Welfare in December 2016 for the suppression of viral replication in chronic hepatitis B patients with evidence of hepatitis B virus replication and abnormal liver function.
Source: Gilead Sciences