Roche has received approval from the European authorities to market the oral influenza drug Tamiflu (oseltamivir phosphate). Marketing authorisation has been granted for the treatment of influenza in adults and children and the prevention of influenza in adolescents and adults, announced by Roche and Gilead Sciences, Inc.
Roche had received a positive recommendation for Tamiflu from the Committee for Proprietary Medicinal Products (CPMP) in March this year. This approval is the fifth market authorisation by the EU for a Roche product this year; it comes only a few days after Roche's heptatis C medicine Pegasys had been approved.
The approval was based on clinical trial data demonstrating that Tamiflu provides rapid recovery from influenza and prevention of complications, by safely and effectively targeting neuraminidase at all sites of infection. Neuraminidase is an enzyme which is important for the replication and spread of the influenza virus, the root cause of influenza illness. Treatment studies in adults show that Tamiflu provides a significant reduction in the severity of symptoms over and above symptom relievers alone, allowing people to feel better faster and to return to their normal lives more quickly.
In children Tamiflu, taken orally as a convenient liquid form also reduced severity of symptoms and reduced the occurrence of otitis media, a secondary infection often seen with influence disease. Tamiflu has been shown to be effective in a variety of settings for the prevention of influenza, providing immediate protection during an influenza outbreak.
In Europe, influenza can affect up to one in ten of the adult population in a normal year, and this number can increase significantly during severe epidemics. Influenza is a common respiratory infection in children with up to one in three children affected each year. Influenza related secondary complications are associated with excess use of antibiotics, hospitalisations and out-patient visits. In the UK in 2000 around 20,000 people died as a result of influenza and its complications.
"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, UK.
Tamiflu is already available for the treatment of influenza in over 40 countries world-wide including Australia, Canada, Japan, Switzerland, United States, as well as many countries in the Far East and Latin America. Around four million patients have been treated with Tamiflu since launch. It is also approved in the United States for the prevention of influenza in adolescents and adults and in the United States and Canada for the treatment of influenza in children aged 1 year and above.
Tamiflu, co-developed with Gilead Sciences, Inc., USA, is a systemic treatment for influenza, designed to reach all key sites of infection in the body including the upper and lower respiratory tracts. The medication targets the neuraminidase protein of the influenza virus. The neuraminidase is virtually the same in all common strains of influenza. If neuraminidase is inhibited, the virus is not able to infect new cells and spread in the body.