Influenza :: Roche files supplemental new drug application for Tamiflu

Roche has filed a supplemental new drug application (sNDA) with the U.S. Food and Drug Administration (FDA) to market Tamiflu (oseltamivir phosphate) capsules in pediatric doses of 30 mg and 45 mg. Tamiflu, which is indicated for the prevention and treatment of influenza types A and B in patients one year and older, is currently available in a 75 mg capsule for adults as well as liquid suspension formulation for children.

With a longer shelf life than the liquid suspension formulation (five years vs. 24 months), Tamiflu pediatric capsules provide a better option for government pandemic stockpiling and can be administered to children for seasonal influenza.

The application was filed based on information already available for the 75 mg capsule. The method of manufacturing will remain the same; the only change will be the size of the capsule and the amount of the active ingredient, oseltamivir phosphate, filled into the capsule. Roche is optimistic that the FDA will complete its review of the sNDA by mid-2007.

Flu’s Impact on Children

Research indicates that children are especially vulnerable to influenza and its complications. On average, one in three children in the U.S. is affected by influenza annually. Children are also two to three times more likely than adults to get sick with the flu, according to the National Institute for Allergies and Infectious Diseases (NIAID).

Additionally, children represent a population that is both highly vulnerable to influenza infection and one of the most important links in its transmission. Experts believe that compared with adults, children do not have as much natural immunity to influenza, because they have had less lifetime exposure. Close contact with each other in school, home and daycare settings increases children’s risk of getting and spreading the virus.

The Centers for Disease Control and Prevention (CDC) recommends three steps to protect against influenza: vaccination, good health/hygiene habits, and antiviral medications. When taken within 12-48 hours of symptom onset, antiviral medications like Tamiflu can help reduce the duration of symptoms. Tamiflu can be used preventively to help avoid the flu altogether. Clinical trials have shown Tamiflu to be up to 89 percent effective in preventing influenza illness when taken within 48 hours of exposure, which can help control spread in the workplace and other crowded settings.

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