GlaxoSmithKline (GSK) has launched Rotarix in Mexico representing the first concrete step for GSK in providing a safe and effective vaccine to prevent rotavirus globally.
GSK Biologicals'Rotarix obtained licensure on July 12th 2004 from the Mexican regulatory authorities. Rotarix will be launched in many other Latin American countries in the course of 2005 and will start also to be launched in Asia Pacific. Rotarix has already been filed in more than 20 countries worldwide.
Jean Stéphenne, president and GM of GSK Biologicals said, "In the case of Rotarix, we focussed our clinical and regulatory strategy first on countries where the medical need for a rotavirus vaccine was amongst one of the highest in the world."
More than 70,000 infants were enrolled in the global clinical development program, for Rotarix, with studies conducted in Europe, the US, Latin America, Africa and Asia. The phase III clinical study in over 60,000 infants aged 6 weeks to 6 months, conducted in 11 Latin American countries and in
Finland confirmed that Rotarix is safe and well tolerated.
Rotarix has demonstrated up to 90 per cent efficacy against severe rotavirus -related gastroenteritis in the first year of life. Rotarix has also demonstrated protection against circulating strains that were different from the vaccine strain, the company says.
Rotarix has been in development at GSK Biologicals since 1997 when it was in-licensed from AVANT Immunotherapeutics. Dr Richard Ward originally developed the vaccine at the Children's Hospital of Cincinnati.
Rotavirus infection is the leading cause of severe diarrhoea and vomiting in infants and young children between 6 and 36 months worldwide. If untreated, the virus can rapidly kill, as the sickest children become dehydrated from 10 to 20 episodes of diarrhoea in a single day. Globally, rotavirus infections account for approximately 138 million cases of infantile gastroenteritis each year and are responsible for approximately 440,000 deaths per year globally - one child a minute.