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Pharmaceutical industry

Roche Seeks FDA Approval for Tamiflu Prophylaxis in Children Ages 1 through 12

Strategic Insights

— 2 min read

Tamiflu, the leading prescription antiviral medication for influenza, is currently indicated for the prophylaxis of influenza in adult patients and adolescents 13 years and older. In a move to expand its market reach, Roche has filed a supplemental new drug application (sNDA) with the U.S. Food and Drug Administration (FDA), requesting an extension of the prophylaxis indication to include children ages 1 through 12. The company is optimistic that the FDA will complete their review of the sNDA before the next flu season, citing the success of Tamiflu in preventing secondary spread of influenza infection and illness in households. According to the U.S. Centers for Disease Control, an average of 36,000 people in the United States die from influenza each year, and children younger than 2 years old are as likely as those over age 65 to be hospitalized due to flu-related illnesses.

Key Takeaways:

  • Roche has filed an sNDA with the FDA to extend the prophylaxis indication of Tamiflu to children ages 1 through 12, currently indicated for adult patients and adolescents 13 years and older.
  • The sNDA was filed based on results from a clinical study enrolling over 1000 patients, including adults and children, which showed that post-exposure prophylaxis is effective in preventing secondary spread of influenza infection and illness in households.
  • The most frequently reported adverse events in pediatric patients were gastrointestinal events, particularly vomiting.
  • Tamiflu is the leading prescription antiviral medication for influenza, working by targeting the neuraminidase protein on the surface of the influenza virus.
  • According to the U.S. Centers for Disease Control, an average of 36,000 people in the United States die from influenza each year, with children under 2 years old as likely to be hospitalized due to flu-related illnesses as those over 65.
  • Roche is optimistic that the FDA will complete their review of the sNDA before the next flu season, citing the success of Tamiflu in preventing secondary spread of influenza infection and illness in households.
  • Stockpiling Tamiflu in advance is advised by the World Health Organization (WHO) as the only way to ensure sufficient supplies in the event of a pandemic.
  • Roche is in discussions with the U.S. Department of Health and Human Services (HHS), which purchased 2.3 million Tamiflu treatment courses in 2004.

Statistics:

  • An average of 36,000 people in the United States die from influenza each year.
  • Over 200,000 people are hospitalized due to flu-related illnesses each year.
  • Children under 2 years old are as likely as those over 65 to be hospitalized due to flu-related illnesses.
  • One in 10 adults is affected by influenza annually, compared with one in three children.
  • 2.3 million Tamiflu treatment courses were purchased by the U.S. Department of Health and Human Services (HHS) in 2004.

Sources:

  • U.S. Food and Drug Administration (FDA)
  • Roche
  • U.S. Centers for Disease Control (CDC)
  • World Health Organization (WHO)
  • U.S. Department of Health and Human Services (HHS)
  • Gilead Sciences, Inc.

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