Sanofi wins first dengue vaccine market approval in Mexico
By Matthias Blamont and Noëlle Mennella
PARIS Dec 9 (Reuters) - Sanofi's dengue vaccine is to make its market debut in Mexico, the French drugmaker said on Wednesday, adding that it expects to have filed for market approval in some 20 countries by year-end.
Sanofi Pasteur, the group's vaccines division, said Mexico had approved the preventive treatment, called Dengvaxia, for all four dengue virus serotypes, but only for patients aged 9 to 45 who live in areas where the disease is endemic.
This means the world's first dengue vaccine has no approval yet for use on young children, a population considered to be most at risk, or for use by tourists.
Dengue fever is a mosquito-borne disease caused by four virus serotypes (1 to 4) as categorised by the World Health Organisation. Overall, the disease is seen as a threat to about half of the world's population. Some 400 million people are believed to be infected annually.
Guillaume Leroy, who leads the dengue team at Sanofi Pasteur, said the vaccine acted best as an immune booster for patients with some previous exposure.
He told Reuters in an interview that additional data over the coming years would be needed to assess whether the vaccine may be of use to travellers.
"Health authorities will have to determine (future) recommendations," he said, adding Sanofi's first 20 market approval requests were all in South America and Asia. Europe is the target for early next year and the United States in early 2017, he said.
"Mexico is one of the countries where we started our clinical trials, which has been associated with the programme from the very beginning and whose regulatory authority is certified by the WHO," said Olivier Charmeil, Sanofi's executive vice president, vaccines. Continuación...