The US Food and Drug Administration has approved Roche’s supplemental new drug application (sNDA) extending the prophylaxis (prevention) indication for Tamiflu (oseltamivir phosphate) to include children aged from one to twelve.
According to a Roche release, the leading prescription antiviral medication for prevention and treatment of influenza, Tamiflu was previously approved for prophylaxis in adolescents (age 13 years and older) and adults. Tamiflu is also the only antiviral medication indicated for the treatment of influenza type A or type B infection in patients one year and older, and is available in both capsule and liquid suspension formulations.
William M. Burns, CEO Division Roche Pharma, said, “Very young children are particularly vulnerable during any outbreak of influenza. The approval of Tamiflu in this indication enables doctors to have a safe and effective medicine at hand to help prevent young children from getting influenza. The data which the submission was based on confirms the importance of Tamiflu in the management of influenza”.
When administered within 48 hours of exposure, clinical data show that prophylaxis with Tamiflu reduced the incidence of flu from 17 per cent in the group not receiving Tamiflu to 3 per cent in the group receiving prophylaxis. The dosing for the new indication is 30 mg to 60 mg once daily (dependant on body weight) for a duration of 10 days. Therapy should begin within two days of exposure, following close contact with an infected individual.
The sNDA was filed 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, which included more than 1,000 patients (including adults and children), showed that post-exposure prophylaxis is effective in preventing secondary spread of influenza infection and illness in households and that the protective efficacy of Tamiflu was the same in children aged one through 12 as the whole population, added the release.
Tamiflu gained a positive opinion in Europe and Switzerland for prevention of influenza in children 1 to 12 years last week.
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 hospitalised 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.