FDA backs Gilead's Viread for children

The US Food and Drug Administration has approved US biotech firm Gilead Sciences (Nasdaq: GILD) Viread (tenofovir disoproxil fumarate) in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients aged two to 12.

Gilead says the FDA approved a supplemental New Drug Application for three lower-strength once-daily tablets of Viread in doses of 150mg, 200mg and 250mg for children aged six to 12. The agency also approved a New Drug Application for an oral powder formulation of Viread for children aged two to five.

Viread was originally approved by the FDA in 2001 as a once-daily 300mg tablet for individuals aged 18 and over for the treatment of HIV-1 infection in combination with other antiretrovirals. In March 2010, the 300mg dose was approved for use in the USA among adolescents aged 12-17. In pediatric patients, the use of either the lower-strength tablets or the oral powder formulation of Viread is based on the patient’s age and weight. The safety and efficacy of Viread has not been established in children less than two years of age. In HIV-infected adult patients, the dose is one 300 mg Viread tablet once daily taken orally, without regard to food. For adults unable to swallow Viread tablets, the oral powder formulation equal to 300 mg may be used.