Roche announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) to market Tamiflu(R) (oseltamivir phosphate) capsules in 30 mg and 45 mg doses. The lower dose capsules provide a convenient alternative for the treatment and prevention of influenza types A and B in patients one year and older. Since the capsules have a longer shelf life than the liquid suspension formulation (five years vs. 24 months), they also offer an improved option for government pandemic stockpiling.
Tamiflu will continue to be available in a 75 mg capsule for adults as well as liquid suspension formulation for children. The 30 mg and 45 mg capsules will be available in pharmacies nationwide and for government stockpiling for the 2007-2008 flu season. To date, Roche has filled orders from the U.S. federal government and states for 43.7 million Tamiflu treatment courses.
"Roche continues to take steps to facilitate the use of antivirals in pandemic preparedness and response," said Dominick Iacuzio, Ph.D, medical director at Roche. "These lower dose capsules not only provide governments with a new option for pandemic stockpiling, but also give prescribing physicians an alternative for patients who prefer a capsule formulation."
The sNDA was filed in March based on data 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. Tamiflu is the only neuraminidase inhibitor approved for use in children one to five years of age.
Influenza is a serious illness that affects up to 40 million Americans every year, leading to approximately 200,000 hospitalizations and 36,000 deaths.(1) 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.(2) 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).(3)
Additionally, children represent one of the most important links in influenza transmission.(4) 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 also 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 schools and other crowded settings.