Tamiflu gains positive opinion in Europe and Switzerland for prevention of influenza in children 1 to 12 years
Basel, 15 December 2005, Roche announced today that its anti-influenza medicine Tamiflu (oseltamivir) has received a positive opinion from the European and Swiss authorities for the prevention of influenza (prophylaxis use) in children aged one to 12 years. A filing for the same indication was submitted in the United States in April this year and an approval is expected early next 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.
Eduard Holdener, Head of Global Pharma Development in Roche’s Pharmaceutical Division commented: “After approval by the European Commission and Swissmedic, 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 is 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.
• 38 percent reduction in the severity of symptoms
• 67 percent reduction in secondary complications such as bronchitis, pneumonia and sinusitis in otherwise healthy individuals
• 37 percent reduction in the duration of influenza illness
• Tamiflu is shown to provide up to 89 percent overall protective efficacy against clinical influenza in adults and adolescents who had been in close contact with influenza-infected patients
In children, treatment with Tamiflu delivers:
• 36 percent reduction in the severity and duration of influenza symptoms
• 44 percent reduced incidence of associated otitis media as compared to standard care
The World Health Organization (WHO) advises that stockpiling antivirals in advance is presently the only way to ensure that sufficient supplies are available in the event of a pandemic. Roche has been working closely with WHO and national governments to ensure governments are aware of the importance of stockpiling antivirals in the event of a pandemic situation. Roche has received and fulfilled pandemic orders for Tamiflu from around 50 countries worldwide. The magnitude of these orders varies with some countries, France, Finland, Iceland, Ireland, Luxembourg, Netherlands, New Zealand, Norway, Switzerland and UK stockpiling or intending to stockpile adequate Tamiflu to cover 20-40% of their population. To meet this demand Roche has already significantly expanded its Tamiflu production capacity several times, and will continue to take action, both on its own and with several partners, to increase production capacity to assist governments with their pandemic preparedness.
Roche and Gilead
Tamiflu was discovered by Gilead and developed jointly by Gilead and Roche. Roche has exclusive world-wide rights for the manufacturing and marketing of Tamiflu and continues to work in partnership with Gilead.
Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2004 sales by the Pharmaceuticals Division totalled 21.7 billion Swiss francs, while the Diagnostics Division posted sales of 7.8 billion Swiss francs. Roche employs roughly 65,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet (www.roche.com).
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