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Roche (RHHBY) Files Supplemental New Drug Application To Extend Prophylaxis Indication For Tamiflu(R) To Patients Between 1-12 Years Of Age



10/19/2005 5:13:04 PM

NUTLEY, N.J., April 18 /PRNewswire/ -- Roche has filed a supplemental new drug application (sNDA) with the U.S. Food and Drug Administration (FDA), requesting an extension of the prophylaxis indication for Tamiflu(R) (oseltamivir phosphate) to include children ages one through 12. Currently, Tamiflu is indicated for the prophylaxis of influenza in adult patients and adolescents 13 years and older. Tamiflu is also indicated for the treatment of uncomplicated acute illness due to influenza type A or type B infection in patients one year and older who have been symptomatic for no more than two days. Roche is optimistic that FDA will complete their review of the sNDA before the next flu season.

The sNDA was filed based on results from a subset of pediatric patients in a clinical study where Tamiflu was used for the management of influenza in households. The study enrolled over 1000 patients in total (including adults and children). The study overall showed that post-exposure prophylaxis is effective in preventing secondary spread of influenza infection and illness in households and that the protective efficacy of Tamiflu was the same in children aged one through 12 as the whole population. Gastrointestinal events, particularly vomiting, were the most frequently reported adverse events in pediatric patients.

Tamiflu is the leading prescription antiviral medication for influenza. It works by targeting one of the two major surface structures of the influenza virus, the neuraminidase protein. The neuraminidase site is virtually the same in the most common strains of influenza, types A and B. Tamiflu attacks the influenza virus and is thought to work by stopping it from spreading inside the body. Tamiflu treats flu at its source, by attacking the virus that causes the flu, rather than simply masking symptoms.

Flu's Impact on Children

According to the U.S. Centers for Disease Control, an average of 36,000 people in the United States die from influenza each year while more than 200,000 people are hospitalized due to flu-related illnesses. Children younger than two years old are as likely as those over age 65 to be hospitalized because of the flu. It is estimated that children are three times more likely to get sick with the flu - on average, one in 10 adults is affected by influenza annually, compared with one in three children. Therefore, prevention of influenza in children can have a significant impact on the spread of influenza in the household and the whole community.

Pandemic Stockpiling

The World Health Organization (WHO) advises that stockpiling the drugs in advance is presently the only way to ensure that sufficient supplies are available in the event of a pandemic. Countries such as the United Kingdom, France, Canada and Finland have already ordered significant quantities as part of their pandemic plans. Roche is also in discussions with the U.S. Department of Health and Human Services (HHS), which purchased 2.3 million Tamiflu treatment courses in 2004. Since then, the increasing global threat of a bird flu pandemic has driven attention to the need for additional antiviral stockpiles.

About Tamiflu

Tamiflu, co-developed by Gilead Sciences, Inc. is a systemic treatment for the most common strains of influenza (types A and B).

Tamiflu is generally well tolerated. In treatment studies in adults, the most frequently reported adverse events were mild-to-moderate transient nausea and vomiting. Other events reported more frequently than with placebo were bronchitis, insomnia and vertigo. In prophylaxis studies in patients aged 13 and older, adverse events were qualitatively similar to those seen in the treatment studies despite a longer duration of dosing. Events reported more frequently in subjects receiving Tamiflu compared to subjects receiving placebo in prophylaxis studies included nausea, vomiting, diarrhea, abdominal pain, dizziness, insomnia, headache, vertigo and fatigue.

In pediatric treatment studies, the most frequently reported adverse event was vomiting. Other events reported more frequently by pediatric patients treated with Tamiflu included abdominal pain, epistaxis, ear disorder and conjunctivitis. These events generally occurred once and resolved despite continued dosing. In a prophylaxis study which included pediatric patients aged one to 12 years, gastrointestinal events were most frequently reported, particularly vomiting.

Efficacy of Tamiflu in the treatment of subjects with chronic cardiac disease and/or respiratory disease has not been established.

Tamiflu was approved by the U.S. Food and Drug Administration (FDA) for the treatment of uncomplicated acute illness due to influenza infection in adults in October 1999.

The FDA granted marketing approval for the prevention of naturally occurring influenza A and B in adults and adolescents 13 years and older in November 2000. The FDA granted marketing approval of the oral suspension for use in the treatment of influenza A and B in children one year and older in December 2000. Tamiflu oral suspension is used for pediatric patients one year and older or adult patients who cannot swallow a capsule. Tamiflu is the first and only liquid suspension to treat influenza A and B.

Vaccination is considered the first line of defense against influenza.

Tamiflu is available for the treatment of influenza in more than 40 countries worldwide. For more information visit http://www.tamiflu.com/

About Roche - More Than a Century in the U.S. and the World

Founded in 1896 and headquartered in Basel, Switzerland, Roche is one of the world's leading innovation-driven healthcare groups. Its core businesses are pharmaceuticals and diagnostics. Roche is one of the world's leaders in diagnostics, the leading supplier of pharmaceuticals for cancer, as well as a leader in virology and transplantation. As a supplier of products and services for the prevention, diagnosis and treatment of disease, the Group contributes on many fronts to improve people's health and quality of life. Roche employs roughly 65,000 people in 150 countries, including approximately 15,000 in the United States.

Roche's U.S. operations celebrate their American Centennial in 2005. In another milestone this year, Roche was named in January to Fortune magazine's list of Best Companies to Work for in America. One of an increasingly rare breed of major healthcare companies that still bear their original name, Roche today has more than a dozen U.S. sites located in California, Colorado, Indiana, New Jersey and South Carolina, as well as in Puerto Rico. Roche has alliances and research and development agreements with numerous partners, including majority ownership interests in Genentech and Chugai. Roche's Pharmaceuticals Division offers a portfolio of leading medicines in therapeutic areas including cancer, HIV/AIDS, hepatitis C, transplantation, dermatology and influenza. Roche's Diagnostics Division supplies a wide array of innovative testing products and services to researchers, physicians, patients, hospitals and laboratories world-wide. For further information, visit the worldwide and U.S. websites (Global: http://www.roche.com/ and U.S.: http://www.roche.us/).

Roche

CONTACT: Terence Hurley of Roche, +1-973-562-2882,terence_j.hurley@roche.com; or Sue Preziotti of Fleishman-Hillard,+1-212-453-2144, preziots@fleishman.com, for Roche


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