Gilead Sciences receives EU approval for new Viread indications

Gilead Sciences has received European Commission approval for a pair of new indications of its antiretroviral therapy Viread.

The drug has been ratified in combination with other antiretroviral agents for the treatment of HIV-1 patients aged two to 18 years who suffer from nucleoside reverse transcriptase inhibitor resistance or toxicities that preclude the use of first-line paediatric agents.

It has also been approved for use against chronic hepatitis B virus infections in adolescent patients aged 12 to 18 years with compensated liver disease and evidence of immune active disease.

These new indications are supported by evidence from a trio of clinical studies showing the safety and efficacy of Viread among these patient groups.

Dr Norbert Bischofberger, executive vice-president for research and development and chief scientific officer at Gilead Sciences, said: "We are pleased to provide new therapeutic options for younger patients living with HIV and chronic hepatitis B and will work to make these paediatric formulations available as quickly as possible."

Earlier this week, the firm also reported positive data from a phase III clinical trial of sofosbuvir, its new therapy for hepatitis C.