Sanofi has won the first-ever regulatory approval for a vaccine against dengue fever, with a green light for Dengvaxia in Mexico.
The company said the first marketing authorisation for the vaccine “is a historic milestone paving the way to significantly impact dengue burden in endemic countries” and marks the fruition of more than two decades of R&D effort costing around $1.6bn.
The first commercial doses of the vaccine have already been produced and full scale production capacity will reach 100m doses a year, according to Sanofi. Around 40,000 people will receive the treatment in Mexico in an initial roll-out.
Mexico’s COFEPRIS agency has approved Dengvaxia for the prevention of disease caused by all four dengue virus serotypes in people – aged between 9 and 45 – who live in areas where the disease is endemic.
Although dengue affects people from all ages and walks of life, the greatest number of dengue cases worldwide occurs in the highly mobile and social segment of the population that includes preadolescent to adult ages, according to French pharma group.
Around half the world’s population is at risk of developing dengue fever, which hospitalises half a million people every year. While the burden is most felt in Asia and Latin America, its incidence is on the increase in many other areas of the world as travellers bring the virus back with them from trips abroad.
Dengue is spread by the Aedes aegypti mosquito and symptoms include fever, a hammering headache, flu-like symptoms, bone, muscle and joint pain, rash and nausea and vomiting. While generally self-limiting, some patients can develop severe disease leading organ damage that kills around 22,000 people a year, according to the World Health Organization (WHO).
The approval is based on clinical trials which showed that the vaccine could reduce dengue in two thirds of patients and prevented 90% of severe cases and 80% of hospitalisations.
Dengvaxia will be rolled out rapidly and pent-up demand will mean saes grow quickly to a peak of around $1.4bn a year, according to pharma industry analysts. Sanofi will also have the market to itself for some time, as nearest rival Takeda‘s DENvax candidate is still in phase II trials.