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Sanofi files for JE vaccine approval

Sanofi Pasteur has filed marketing authorisation applications in Thailand and Australia for its vaccine against Japanese encephalitis

Sanofi Pasteur, the vaccines division of sanofi-aventis group, has filed marketing authorisation applications in Thailand and Australia for IMOJEV, its single-dose vaccine against Japanese encephalitis (JE).

JE affects 30,000 to 50,000 people each year in Asia, of which 10,000 die.

"The goal of Sanofi Pasteur is to provide an innovative Japanese encephalitis vaccine to people who most need it in order to improve public health in countries where the disease is endemic," said Wayne Pisano, chief executive officer of Sanofi Pasteur.

"We believe IMOJEV single-dose vaccine has the potential to transform JE vaccination in Asia and help reduce the burden of this devastating disease."

The marketing authorisation files are under review by the Therapeutic Goods Administration in Australia (TGA), and by the Food and Drug Administration in Thailand (TFDA), which is giving the vaccine a fast-track review. Clinical studies, involving over 3,800 children and adults in the US, Australia, Thailand and the Philippines, evaluated the safety and ability to generate a protective immune response with one dose of the vaccine.

IMOJEV was compared to licensed Japanese encephalitis vaccine, JE-VAX, and placebo in adults, and to a control vaccine in children. A Phase III study in adults showed that a single dose of IMOJEV was as immunogenic as three doses of JE-VAX, eliciting a protective level of neutralising antibodies in 93.6 per cent and 99 per cent of subjects 14 days and one month after vaccine administration, respectively. A Phase III study in children showed that 95 per cent of JE virus naive subjects were seroprotected one month after a single dose of IMOJEV.

8th July 2009

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