Roche Files Supplemental New Drug Application with U.S. Food & Drug Administration for Tamiflu 30 mg and 45 mg Capsules
NUTLEY, N.J., March 09, 2007 /PRNewswire/ -- 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.(1) 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).(2)
Additionally, children represent a population that is both highly vulnerable to influenza infection and one of the most important links in its transmission.(3) 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.
Roche's Efforts to Support Pandemic Stockpiling
The World Health Organization (WHO) advises that stockpiling antivirals in advance is presently the only way to ensure that sufficient supplies are available in the event of a pandemic. Roche has been working closely with WHO and national governments to ensure governments are aware of the importance of stockpiling antivirals in the event of a pandemic situation. Roche has received and fulfilled pandemic orders for Tamiflu from more than 75 countries worldwide.
Roche has also donated 5.125 million courses of Tamiflu treatment to the WHO for international rapid response and regional response to a pandemic influenza strain.
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 Centers for Disease Control and Prevention.
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.
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, the Roche Group 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. An employer of choice, in 2006, Roche was named one of the Top 20 Employers (Science magazine), ranked the No. 1 Company to Sell For (Selling Power), and one of AARP's Top Companies for Older Workers, and in 2005, Roche was named one of Fortune magazine's Best Companies to Work For in America. For additional information about the U.S. pharmaceuticals business, visit our websites: http://www.rocheusa.com or www.roche.us.
(1) Thompson, WW. et al. Influenza-Associated Hospitalizations in the United States. Journal of the American Medical Association 2004; Vol. 292, No. 11, 1333-40. (2) National Institute of Allergy and Infectious Diseases. "Flu." Retrieved on 2/15/07. http://www.niaid.nih.gov/factsheets/flu.htm. (3) Dolin R. Influenza - interpandemic as well as pandemic disease. New England Journal of Medicine 353; 24. P. 2535-37. December 15, 2005
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Posted: March 2007
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