Hoffmann-La Roche Inc and Gilead Sciences Inc announced that the U.S. Food and Drug Administration (FDA) has granted Roche marketing approval for a paediatric treatment indication for Tamiflu (oseltamivir phosphate), the number one prescribed antiviral treatment for influenza in adults.
The paediatric indication, which will be available by mid-January 2001 in a liquid suspension, is for the treatment of acute illness due to influenza in children 1 year and older who have been symptomatic for no more than two days. The suspension for paediatric patients can also be used for adults who cannot swallow a capsule.
Tamiflu, the first pill to treat the most common strains of influenza, types A and B, received government approval in October 1999, for the treatment of uncomplicated acute illness due to influenza infection in adults. On November 17 of this year, Roche received marketing approval for a prophylaxis indication for Tamiflu in adolescents and adults. In addition, earlier this week Roche received marketing approval in Japan for the treatment of influenza in adults.
Paediatric clinical studies show that Tamiflu reduced the duration of influenza by 1.5 days (26 percent) in children aged 1-12 when given within two days of onset of symptoms. Children were administered Tamiflu in a tutti-frutti flavored oral suspension formulation.
In discussing these results, Keith Reisinger, Pittsburgh Pediatric Research and investigator in the paediatric trials of Tamiflu, said, "The incidence of influenza in children is significantly higher than in healthy adults. However, up until now, treatment of influenza A & B has not been available for all ages of children. Given Tamiflu's convenient mode of administration and good safety profile, it will fill a previously unmet medical need and be of great use to paediatricians during the winter flu season."