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Pharmaceutical industry

Roche Announces FDA Approval of Tamiflu for Infants as Young as Two Weeks Old

Strategic Insights

— 1 min read

The U.S. Food and Drug Administration (FDA) has extended the approval of Tamiflu, a prescription oral antiviral medicine, to include infants two weeks of age and older, making it the only approved medicine for people of all ages. This approval provides parents with a treatment option for their young children, particularly since the Centers for Disease Control advises against vaccinating infants less than six months of age. Tamiflu has been a widely used medicine for over 13 years, with approximately 30 million children worldwide and 6.9 million in the United States receiving a prescription.

Key Takeaways:

  • The FDA approval of Tamiflu for infants two weeks of age and older expands its use to include people of all ages, from infants to elderly individuals.
  • The approval is based on two open-label safety and pharmacokinetic studies conducted in 136 infants less than one year of age infected with influenza.
  • The clinical trials demonstrated a similar safety and efficacy profile for infants as that observed in older children and adults.
  • Tamiflu is designed to be active against all clinically relevant influenza viruses and works by blocking the action of the neuraminidase enzyme on the virus surface.
  • Over 90 million people from more than 80 countries have received a prescription for Tamiflu to treat or prevent influenza.
  • Approximately 30 million children worldwide and 6.9 million in the United States have received a prescription for Tamiflu.
  • The medicine is indicated for the treatment of acute, uncomplicated influenza in patients two weeks of age and older and for preventing influenza in patients one year and older.

Statistics:

  • 30 million children worldwide have received a prescription for Tamiflu.
  • 6.9 million children in the United States have received a prescription for Tamiflu.
  • Over 90 million people from more than 80 countries have received a prescription for Tamiflu.
  • 136 infants less than one year of age were involved in the open-label safety and pharmacokinetic studies.
  • 13 years: the amount of time since Tamiflu was first approved in the United States.

Sources:

  • i. Roche Press Release: "Roche announces FDA approval of Tamiflu for the treatment of acute, uncomplicated influenza in infants as young as two weeks old" (December 2022)
  • ii. Roche Data on File: "Tamiflu efficacy and safety in infants under one year of age" (2022)

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