EU approvals for Viread and Constella; EMA accepts vintafolide MAA

Among a batch of European Union regulatory news in the last day or two, US biotech firm Gilead Sciences (Nasdaq: GILD) announced that the European Commission has granted marketing authorization for two new indications for once-daily Viread (tenofovir disoproxil fumarate).

The first permits the use of Viread in combination with other antiretroviral agents for the treatment of HIV-1 infected pediatric patients aged two to less than 18 years with nucleoside reverse transcriptase inhibitor (NRTI) resistance or toxicities precluding the use of first line pediatric agents.

Additionally, Viread is now approved for the treatment of chronic hepatitis B virus (HBV) infection in adolescent patients aged 12 to less than 18 years with compensated liver disease and evidence of immune active disease. Viread was approved for use in combination with other antiretroviral agents as a treatment for HIV-1 infection in adults and for chronic HBV in 2002 and 2008, respectively, and is the most-prescribed molecule for these diseases in major European countries.