NUTLEY, NJ — March 21, 2002 — Roche and Gilead Sciences, Inc. announced today that the European Committee for Proprietary Medicinal Products (CPMP), the scientific committee of the European Medicines Evaluation Agency (EMEA), has recommended granting Tamiflu® (oseltamivir phosphate) Marketing Authorization in the European Union (EU) for the treatment of influenza in adults and children and the prevention of influenza in adolescents and adults.
Tamiflu has been available in the United States since it was approved by the U.S Food and Drug Administration (FDA) in 1999, and has helped millions of people reduce the duration of the flu. Roche anticipates that Tamiflu will play an important role in the management of influenza in Europe.
"Access to new antivirals such as Tamiflu is important for physicians and patients. It means that the medical profession will have a new weapon to fight the influenza virus, which affects many people every year in Europe, knocking them flat and causing severe complications and death," commented Professor John Oxford, Barts and The London, Queen Mary's School of Medicine and Dentistry, London, England.
The CPMP opinion will serve as the basis for EU regulatory approval, which is typically issued within a few months following a positive recommendation. Upon approval, Tamiflu will be available in Europe next flu season. In Europe, influenza can affect up to one in ten adults in a normal year, and this number can increase significantly during severe epidemics. In the United Kingdom, about 20,000 people died as a result of influenza and its complications in 2000. In the US, approximately 40 million Americans contract the flu virus each year.
"During past flu seasons in the US, antivirals, such as Tamiflu, helped my patients decrease the duration of their flu bout and lessen the burden that the flu could have imposed on their lives," said Donald B. Perlman, M.D., Practicing Physician, Clinical Assistant Professor, University of Medicine of New Jersey. "It is promising to see that this advancement in influenza treatment will now be available to a wider audience in Europe."
Tamiflu is available for the treatment of influenza in over 40 countries world-wide, including the United States, Japan, Australia, Canada, Korea, Switzerland and many Latin American countries. Around four million patients have been treated with Tamiflu since launch. It is also approved in the US for the prevention of influenza in adolescents and adults, and in the US and Canada for the treatment of influenza in children aged 1 year and above.
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