Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has extended the approval of Tamiflu
(oseltamivir phosphate) for the treatment of acute, uncomplicated influenza to include infants two weeks of age and older.
Tamiflu is prescribed by doctors to help lessen the duration and severity of influenza by blocking the virus’ ability to replicate in the body.
The approval makes Tamiflu the only prescription oral antiviral medicine approved to treat people of all ages, from infants two weeks of age to elderly people. Tamiflu was first approved in the United States over 13 years ago.
Approximately 30 million children worldwide over the age of one, including an estimated 6.9 million children in the United States, have received a prescription for Tamiflu.
“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,” said Hal Barron, M.D., chief medical officer and head, Global Product Development.
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 infants less than one year of age was consistent with other populations.
Tamiflu, co-developed by Gilead Sciences Inc, works by blocking the action of the neuraminidase enzyme on the surface of the influenza virus. When neuraminidase is inhibited, the virus is restrained from spreading to other cells in the body.