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FDA Extends Flu Therapy Approval for Infants

Baby laughing (D Sharon Pruitt/Flickr)The U.S. Food and Drug Administration on Friday approved the prescription of oseltamivir phosphate to treat acute, uncomplicated influenza in children as young as two weeks in age. Oseltamivir phosphate, developed by Genentech, a division of the pharmaceutical company Roche in South San Francisco, California, is marketed under the brand name Tamiflu.

Tamiflu blocks the action of the neuraminidase enzyme on the surface of the influenza virus. Neuraminidase, along with hemagglutinin, are two molecules on the virus surface that control its infectivity. The oseltamivir molecule in the drug binds to the neuraminidase site and prevents the virus from spreading to other cells in the body.

FDA first approved Tamiflu in 1999 to treat adults infected with flu who have shown symptoms for no longer than two days.The drug has since been approved to treat flu in children ages 1 year and older who also show symptoms of flu for no longer than two days, and for the prevention of flu in adults and children ages 1 year and older. Genetech estimates some 30 million children worldwide over the age of one, including nearly 7 million children in the U.S., have received a Tamiflu prescription.

FDA based the extension of Tamiflu on two open label safety and body-function interaction studies conducted with 135 infants less than one year of age infected with influenza. The studies assessed how Tamiflu was absorbed and distributed in the body and how well it was tolerated in this group. The clinical trials showed that the safety profile in infants less than one year of age was consistent with other populations, and the most common side effects reported with Tamiflu in this age group were vomiting and diarrhea.

As a result of these clinical studies, a Tamiflu dose of 3 milligrams per kilogram weight, 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. However, FDA notes these smaller doses will require a different dispenser than what is currently packaged with Tamiflu. “Pharmacists must provide the proper dispenser when filling a prescription so parents can measure and administer the correct dose to their children,” says Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.”

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Photo: D. Sharon Pruitt/Flickr

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