Healthcare Industry News:  influenza vaccine 

Biopharmaceuticals FDA

 News Release - July 2, 2007

Tamiflu(R) 30 mg and 45 mg Capsules Approved by U.S. Food and Drug Administration

Lower Dose Capsules Provide Alternative to Liquid Suspension for Pediatric Administration

NUTLEY, N.J., July 2 (HSMN NewsFeed) -- Roche announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) to market TamifluŽ (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.

Flu's Impact on Children

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.

Roche's Efforts to Support Pandemic Stockpiling

Experts agree that antivirals such as Tamiflu are an essential part of any plan to help control the spread of a pandemic flu virus and potentially reduce illness, hospitalizations and deaths. Roche has taken a number of steps to increase availability and accessibility of Tamiflu over the past several years. The company has received and is filling on schedule orders totaling 215 million treatment courses from more than 75 countries.

Roche has also donated 5.1 million Tamiflu treatment courses to the World Health Organization to contain an initial pandemic outbreak and granted four sub-licenses for production to companies in China, India and Africa.

About Tamiflu

Tamiflu, co-developed by Gilead Sciences, Inc., based in Foster City, CA, is a systemic treatment for the most common strains of influenza (types A and B). Tamiflu is indicated for the treatment of uncomplicated influenza caused by viruses types A and B in patients one year and older who have had flu symptoms for no more than two days. Tamiflu is also indicated for the prevention of influenza in patients one year and older. Tamiflu is not a substitute for annual early vaccination as recommended by the CDC.

Tamiflu has not been shown to be effective against any illness other than that caused by influenza types A and B. Efficacy of treatment in patients with chronic cardiac and/or respiratory disease has not been established. No difference in the incidence of complications was seen between the treatment and placebo groups in this population. No information is available regarding treatment of influenza in patients at imminent risk of requiring hospitalization. Efficacy of Tamiflu has not been established in immunocompromised patients.

Safety and efficacy of repeated treatment or prophylaxis courses have not been studied. In post-marketing experience, rare cases of anaphylaxis and serious skin reactions, including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme, have been reported.

There have been postmarketing reports (mostly from Japan) of self-injury and delirium with the use of Tamiflu in patients with influenza. The reports were primarily among children. The relative contribution of the drug to these events is not known. Patients with influenza should be closely monitored for signs of abnormal behavior throughout the treatment period.

In treatment studies in adult patients, the most frequently reported adverse events (incidence greater than or equal to 1%) were nausea and vomiting. Other events reported numerically more frequently in patients taking Tamiflu compared with placebo were bronchitis, insomnia and vertigo. In treatment studies in patients one to 12 years old, the most frequently reported adverse event (incidence greater than or equal to 1%) was vomiting (15%). Other events reported more frequently in patients taking Tamiflu compared with placebo included abdominal pain (5% vs. 4%), nosebleed (3% vs. 3%), ear disorder (2% vs. 1%) and pink eye (1% vs. <1%).

In prophylaxis studies in adult patients, adverse events were similar to those seen in the treatment studies. Events reported more frequently in patients taking Tamiflu compared with placebo (incidence greater than or equal to 1%) were nausea (7% vs. 3%), vomiting (2% vs. 1%), diarrhea (3% vs. 2%), abdominal pain (2% vs. 1%), dizziness (1% vs. 1%), headache (18% vs. 18%) and insomnia (1% vs. 1%). In a household prophylaxis trial that included patients one to 12 years old, adverse events were similar to those observed in pediatric treatment studies, with GI events being the most common.

The concurrent use of Tamiflu and live attenuated influenza vaccine (LAIV) intranasal has not been evaluated. However, due to the possibility for interference between these products, LAIV should not be given within 2 weeks before or 48 hours after taking Tamiflu, unless it is deemed appropriate by your doctor. Trivalent inactivated influenza vaccine can be administered at any time relative to use of Tamiflu.

Tamiflu is available for the treatment of influenza in more than 80 countries worldwide.

About Roche

Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. pharmaceuticals headquarters of the Roche Group, one of the world's leading research-oriented healthcare groups with core businesses in pharmaceuticals and diagnostics. For more than 100 years in the U.S., Roche has been committed to developing innovative products and services that address prevention, diagnosis and treatment of diseases, thus enhancing people's health and quality of life.

For additional information about the U.S. pharmaceuticals business, visit our websites: or

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(2) Thompson, WW. et al. Influenza- Associated Hospitalizations in the United States. Journal of the American Medical Association 2004; Vol. 292, No. 11, 1333-40.

(3) National Institute of Allergy and Infectious Diseases. "Flu." Retrieved on 2/15/07.

(4) Dolin R. Influenza - interpandemic as well as pandemic disease. New England Journal of Medicine 353; 24. P. 2535-37. December 15, 2005

Source: Roche Group

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