Sanofi ‘s experimental vaccine for tropical disease dengue fever has cleared a second phase III trial, putting the company on course for regulatory filings early in 2015.
The 21,000-patient trial in children and adolescents aged nine to 16 was conducted in Latin America and met its main goal, with three doses of the vaccine given over a 12-month period providing protection against each of the four disease serotypes.
The mosquito-borne dengue fever is endemic in 110 countries worldwide – placing half the world’s population at risk – and leads to around 500,000 hospitalisations and 22,000 deaths every year, according to the World Health Organisation (WHO).
Most cases, while debilitating, can be managed with supportive care, but in a small proportion patients develop a serious condition known as dengue haemorrhagic fever that can be life-threatening.
Sanofi has previously reported encouraging data from a phase III trial carried out in Asia, and the latest results reinforce the value of the vaccine. In the Latin American trial the risk of developing dengue fever was reduced by 61%, while there was an 80% drop in in hospitalisations for the disease.
“For the first time ever, after 20 years of research and industrial commitment, dengue is set to become a vaccine preventable disease,” said Olivier Charmeil, chief executive of the French pharma company’s Sanofi Pasteur vaccine subsidiary.
If approved and introduced into immunisation programmes, Sanofi’s vaccine could have a major public health impact in areas of the world such as Latin America and Asia but will also help tackle a rising number of cases in other parts of the world as travellers bring the virus back with them from trips abroad.
News of the vaccine data comes just as Japan is struggling to contain its first outbreak of the disease in several decades, with 11 people thought have contracted the infection in Tokyo’s popular Yoyogi Park.
Analysts have predicted the vaccine will be rolled out rapidly if approved and given the pent-up demand will grow quickly to reach peak sales of around $1.4bn a year. The company also has quite a lead in the race to bring a dengue vaccine to market, with tis nearest rival – Takeda’s DENvax – still in phase II testing.