The FDA has expanded the use of Tamiflu to treat children as young as two weeks old who have shown symptoms of flu for no longer than two days
Roche’s drug, which has been on the US market since 1999, is the first medicine approved to treat influenza in infants two weeks of age and older.
The drug, originally developed with Gilead, is designed to help lessen the duration and severity of influenza by blocking the virus’ ability to replicate in the body.
Hal Barron, head of global product development and chief medical officer for Roche, said: “We are very pleased that this approval provides parents with a medicine for children as young as two weeks old, particularly because the Centers for Disease Control advises against vaccinating infants less than six months of age.”
The FDA approval is based on two open label safety and pharmacokinetic studies conducted in 136 infants less than one year of age infected with influenza, which assessed how Tamiflu was absorbed and distributed in the body and how well it was tolerated in this group.
Based on these studies, a 3 mg/kg dose of Tamiflu given twice daily for five days to infants is expected to have a similar safety and efficacy profile to that observed in older children and adults. The clinical trials showed that the safety profile in patients less than one year of age was consistent with other populations, according to the firm.
But this comes as Roche faces increasing pressure in Europe to release withheld data for Tamiflu. The Nordic Cochrane Collaboration and the British Medical Journal, as well as a group of influential British MPs, have called on the firm to publish all of the data for Tamiflu, in order to test its overall efficacy and safety.
They say that by withholding these data, the firm is putting patients at risk as doctors cannot see the full risk/benefit profile of the drug. MPs are also concerned that the UK Government spent around £500 million stockpiling the drug during the flu outbreak in 2009/10 that may not be as good as Roche have made out.
The Swiss firm says it is now looking to create a multi-disciplinary review panel to assess all of the data, nearly four years after it was originally asked for all the raw data sets by the Cochrane Collaboration. It maintains that its drug is safe and effective for its approved uses, and that global regulators have come to the same conclusion.