December 14, 2000
Tamiflu™ Granted FDA Approval for Treatment of Flu in Children
-- Tamiflu™ (oseltamivir phosphate), the number one prescribed antiviral treatment for influenza, now available for children 1 year and older --
Nutley, NJ -- December 14, 2000
Hoffmann-La Roche Inc. and Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted Roche marketing approval for a pediatric treatment indication for Tamiflu™ (oseltamivir phosphate), the number one prescribed antiviral treatment for influenza in adults. The pediatric indication, which will be available by mid-January 2001 in a liquid suspension, is for the treatment of acute illness due to influenza in children 1 year and older who have been symptomatic for no more than two days. The suspension for pediatric patients can also be used for adults who cannot swallow a capsule.
Tamiflu, the first pill to treat the most common strains of influenza, types A and B, received government approval in October 1999, for the treatment of uncomplicated acute illness due to influenza infection in adults. On November 17 of this year, Roche received marketing approval for a prophylaxis indication for Tamiflu in adolescents and adults. In addition, earlier this week Roche received marketing approval in Japan for the treatment of influenza in adults.
Pediatric clinical studies show that Tamiflu reduced the duration of influenza by 1.5 days (26 percent) in children aged 1-12 when given within two days of onset of symptoms. Children were administered Tamiflu in a tutti-frutti flavored oral suspension formulation.
In discussing these results, Keith Reisinger, M.D., Pittsburgh Pediatric Research and investigator in the pediatric trials of Tamiflu, said, “The incidence of influenza in children is significantly higher than in healthy adults. However, up until now, treatment of influenza A & B has not been available for all ages of children. Given Tamiflu's convenient mode of administration and good safety profile, it will fill a previously unmet medical need and be of great use to pediatricians during the winter flu season."
The new indication is supported by findings from Phase III randomized, double-blind placebo-controlled clinical trials involving 1,032 children aged 1-12 years, including 698 otherwise healthy children aged 1-12 and 334 asthmatic children aged 6-12. In total, 515 patients received the Tamiflu oral suspension formulation.
In the study involving otherwise healthy children, Tamiflu reduced the duration of influenza by 1.5 days (26 percent). Duration of influenza was defined as time to alleviation of cough, nasal congestion, resolution of fever, and parental opinion of return to normal health and activity.
Tamiflu was well tolerated. The most common adverse event in the pediatric study was vomiting (approximately 5 percent higher than the placebo group). Other events reported more frequently included abdominal pain, epistaxis, ear disorder, and conjunctivitis. These events generally occurred once, despite continued dosing, and only 8 patients (2 percent) withdrew from this study due to adverse events. Tamiflu is not a replacement for vaccines. Early vaccination on an annual basis is recommended by the Centers for Disease Control’s Immunization Practices Advisory Committee unless vaccination is contraindicated, not available or not feasible.
Serious bacterial infections may begin with influenza-like symptoms or may co-exist with or occur as complications during the course of influenza. Tamiflu has not been shown to prevent such complications.
"The treatment benefit of Tamiflu in children is consistent with what is seen in the adult population, and is particularly exciting because of the high incidence of flu in children," said Dr. Dominick Iacuzio, Medical Director, Hoffmann-La Roche. "The pediatric indication builds on the Tamiflu franchise and further demonstrates Roche’s commitment to influenza management."
Tamiflu (oseltamivir phosphate), co-developed with Gilead Sciences of Foster City, California, is a systemic treatment for all common strains of influenza (types A & B) and is available in a convenient pill form. Tamiflu was approved by the U.S. Food and Drug Administration in October 1999 for the treatment of uncomplicated influenza in adults and is now the market leader in antiviral influenza treatment. In its first season of availability for treatment, Tamiflu amassed more than 58 percent of the market share within the class of antivirals called neuraminidase inhibitors, and garnered more than 30 percent of the overall influenza antiviral market.
About Hoffman-La Roche and Gilead Sciences Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. prescription drug unit of the Roche Group, a leading research-based health care enterprise that ranks among the world’s leaders in pharmaceuticals, diagnostics and vitamins. Roche discovers, develops, manufactures and markets numerous important prescription drugs that enhance people's health, well-being and quality of life. Among the company’s areas of therapeutic interest are: virology, including HIV/AIDS and hepatitis C; infectious diseases, including influenza; cardiology; neurology; oncology; transplantation; dermatology; and metabolic diseases, including obesity and diabetes.
For more information on the Roche pharmaceuticals business in the United States, visit the company’s web site at: www.rocheusa.com. To learn about influenza surveillance and to find out if flu is in your area, log onto www.flustar.com.
Gilead Sciences, Inc., headquartered in Foster City, CA, is an independent biopharmaceutical company that seeks to provide accelerated solutions for patients and the people who care for them. Gilead discovers, develops, manufactures and commercializes proprietary therapeutics for challenging infectious diseases (viral, fungal and bacterial infections) and cancer. Gilead maintains research, development or manufacturing facilities in Foster City, CA; Boulder, CO; San Dimas, CA; Cambridge, UK and Dublin, Ireland and sales and marketing organizations in the United States, Europe and Australia.