Tamiflu Shown to Treat Children 1 Year and Older for Acute Influenza

Strategic Insights -

Tamiflu, the number one prescribed antiviral treatment for influenza, has been shown to effectively treat children aged 1 year and older for acute influenza, a significant medical breakthrough considering the high incidence of the disease in this age group. The new indication was supported by clinical trial data demonstrating a 26% reduction in the duration of influenza in children aged 1-12 who received Tamiflu within two days of symptom onset.

Key Takeaways:

  • Tamiflu has been submitted for a new indication to treat acute illness due to influenza in children 1 year and older.
  • Clinical trial data showed that Tamiflu reduced the duration of influenza by 26% in children aged 1-12 when given within two days of onset of symptoms.
  • The proportion of patients developing acute otitis media was reduced by 40% in children receiving Tamiflu versus those receiving placebo.
  • Tamiflu was well-tolerated, with the most common adverse event being vomiting, which occurred in approximately 5% more children in the Tamiflu group compared to the placebo group.
  • Pediatric studies included 1,029 children aged 1-12 years and were double-blind, placebo-controlled clinical trials.
  • The new indication will bring a safe and convenient antiviral medication to the entire family, according to Dr. Dominick Iacuzio, Medical Director at Hoffmann-La Roche.

Statistics:

  • 69% of patients in the otherwise healthy children study were infected with influenza A.
  • 31% of patients in the otherwise healthy children study were infected with influenza B.
  • 515 patients received the Tamiflu oral suspension formulation in the study involving otherwise healthy children.
  • Children receiving Tamiflu returned to normal health and activity almost two days earlier than those receiving placebo.
  • Vomiting occurred in approximately 5% more children in the Tamiflu group compared to the placebo group.

Sources:

  • "Hoffmann-La Roche Inc. and Gilead Sciences, Inc. Announce Submission of New Tamiflu Indication to the U.S. FDA for the Treatment of Children 1 Year and Older." PR Newswire, June 16.
  • "Tamiflu (oseltamivir phosphate)." Hoffmann-La Roche.
  • "Gilead Sciences, Inc." Gilead Sciences.
  • "Hoffmann-La Roche, Inc." Hoffmann-La Roche.