Tamiflu gains approval in Europe for prevention of influenza in children aged 1 to 12 years

Roche announced today that its anti-influenza medicine Tamiflu (oseltamivir) has received approval from the European authorities for the prevention of influenza (prophylaxis use) in children aged one to 12 years.

An approval for the same indication was received in the United States in December last year.

Tamiflu is already indicated for the treatment of influenza in adults and children aged 1 year and above and for the prevention of influenza in adults and adolescents 13 years and older. Tamiflu is a highly effective influenza drug that works by blocking an enzyme on the surface of the virus which prevents it infecting other cells in the body.

William M. Burns, CEO Division Roche Pharmaceuticals, commented: "The influenza season is just starting in the Northern Hemisphere and Roche plans to make Tamiflu available to prevent influenza in very young children who are particularly vulnerable during an outbreak of the disease. This is particularly helpful in the family setting when one member of the family catches influenza - using Tamiflu for prevention will stop the spread of the disease to other family members."

The application was based on results from a subset of paediatric patients in a clinical study where Tamiflu was used for the management of influenza in households. The study showed that treatment of flu patients with Tamiflu combined with post- exposure prophylaxis of other household members is more effective in preventing secondary spread of influenza infection in the household than treating the patient alone. The protective efficacy of Tamiflu was the same in children aged one to 12 as in the whole population.

Flu's Impact on Children

Influenza is particularly dangerous for the most vulnerable in society and this includes young children and infants. Children younger than two years old are as likely as those over age 65 to be hospitalized because of influenza. It is estimated that children are three times more likely to get sick with the flu - on average, one in 10 adults is affected by influenza annually, compared with one in three children. Therefore, prevention of influenza in children can have a significant impact on the spread of influenza in the household and the whole community.