FDA Approves Tamiflu
Tamiflu is indicated for the treatment of uncomplicated acute illness due to influenza infection in adults who have been symptomatic for no more than two days. The medication, part of a new class of drugs called neuraminidase inhibitors, targets one of the two major surface structures of the influenza virus, the neuraminidase protein. If neuraminidase is inhibited, the virus is not able to effectively replicate and spread to other cells.
The companies conducted two Phase III double-blinded, placebo-controlled clinical trials of Tamiflu; one in the U.S. and the other in international sites. In both studies at the recommended dose, there was a 30% reduction in the median time to improvement in patients receiving Tamiflu compared to patients receiving placebo.
Each year, up to 40 million Americans develop the flu, an average of about 300,000 are hospitalized, and 20,000 to 40,000 people die from influenza and its complications. The economic impact is high as well, costing the U.S. an annual $14.6 billion in physician visits, lost productivity, and lost wages.
Hoffmann-La Roche Inc. is a research-intensive pharmaceutical company that discovers, develops, manufactures, and markets prescription drugs. 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.
Gilead Sciences is an independent biopharmaceutical company that seeks to provide accelerated solutions for patients and the people who care for them. The company discovers, develops, manufactures, and commercializes proprietary therapeutics for infectious diseases (viral, fungal, and bacterial infections) and cancer.
For more information: Hoffmann-La Roche Inc., 340 Kingsland St., Nutley, NJ 07110-1199. Tel: 973-235-5000. Fax: 973-235-7605.