Sanofi Pasteur announces a successfull phase III trial in Latin America and plans to enter the market in 2015
The vaccines division of Sanofi has published the results of their second phase III trial of their dengue vaccine candidate. The study, published in The New England Journal of Medicine, looked at the efficacy of the vaccine in Latin America, and reports positive results similar to those found in the initial phase III trial in Asia.
“We plan to submit the vaccine for licensure in 2015 in endemic countries where dengue is a public health priority,” said Olivier Charmeil, President & CEO of Sanofi Pasteur. “We are committed to supporting countries’ ambitions to significantly impact the human and economic burden of dengue through comprehensive vaccination programs. Our goal is to help meet the WHO’s objectives to reduce dengue mortality by 50% and morbidity by 25% by 2020.”
Every year around half a million children and adults are hospitalised with dengue fever. Sanofi Pasteur’s vaccine is currently leading the charge to be the first dengue vaccine on the market. GSK, Merck and Takeda offer up competition for Sanofi, but in reality it will be a least 2017 before a competitor reaches the market.
Analysing 31,000 participants in 10 countries across Asia and Latin America, each with endemic dengue, the overall result is an efficacy of 60.8% against symptomatic dengue in children and adolescents (9-16) who received three doses of the vaccine. The vaccine also showed a 95.5% effectiveness against sever dengue and an 80.3% reduction in the risk of hospitalization. A safety analysis of the latest study also showed reporting rates similar to those found in the first phase III.
With this second landmark trial out of the way Sanofi can look to push through to market ahead of their competitors, with a plan to apply for licensure in 2015.
Find the press release here.
Find discussion of the Latin American trial here.