Sanofi requests health authorities update information on Dengvaxia, based on new data

Henrietta Strickland
December 1, 2017

"For those not previously infected by dengue virus...the analysis found that in the longer term, more cases of severe disease could occur following vaccination", Sanofi said.

The restrictive measure was adopted after the laboratory presented preliminary data to the agency that point to a risk for individuals who are seronegative for dengue fever in developing more serious forms of the virus after being stung by the Aedes aegypti mosquito which carries and spreads dengue and other viruses. In severe cases, dengue can cause breathing problems, hemorrhaging and organ failure.

While the financial hit may not make much of a dent in Sanofi's fourth quarter earnings, the new data is a setback to the drugmaker's hopes for the vaccine, which was the first treatment ever approved for the virus.

Before the current analysis, a research team past year found that the vaccine-if given to dengue-naïve individuals-"acts very much like a natural infection but without making recipients sick".

For the requested label change, Sanofi is asking doctors to consider whether it's likely an individual has been exposed to dengue, and if they haven't, to hold off. "We are working with health authorities to ensure that prescribers, vaccinators and patients are fully informed of the new findings, with the goal of enhancing the impact of Dengvaxia in dengue-endemic countries".

The company will record a charge in its fourth-quarter results reflecting depreciation of inventories, as well as accelerated depreciation of some assets, it said. The Butantã Institute has also developed a vaccine, but it hasn't yet been introduced into the market. The company said political and economic turmoil had an effect on the launch. The disease affects nearly 4 billion people and claims around 20,000 lives each year, the company said. Further, a "very low" incidence this year in Brazil and Mexico is "is contributing to a lack of sense of urgency", a representative said.

Other reports by Click Lancashire

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