Regulatory Affairs

FDA approves use of Genentech Tamiflu to treat Influenza in infants

PBR Staff Writer Published 25 December 2012

The US FDA has approved the use of Genentech's Tamiflu (oseltamivir phosphate) for the treatment of Influenza in infants aged two weeks and more.

Tamiflu works by blocking the ability of the virus to replicate in the body thereby inhibiting the duration and severity of influenza.

With the approval, Tamiflu becomes the only approved prescription oral antiviral medicine to treat infants two weeks old to adults.

Genentech chief medical officer and global product development head Hal Barron said, "We are very pleased that this approval provides parents with a medicine for children as young as two weeks old, particularly because the CDC advises against vaccinating infants less than six months of age."

FDA approval is supported by positive data from two open label safety and pharmacokinetic studies, which involved 136 influenza-infected infants less than one year of age.