Sanofi's Pasteur division on Wednesday said that it received approval from Mexico's Federal Commission for the Protection against Sanitary Risks to launch Dengvaxia in the country, making it the first vaccine to be licensed in the world for the prevention of dengue. Specifically, the vaccine is indicated for the prevention of disease caused by all four dengue virus serotypes in preadolescents, adolescents and adults aged nine to 45 who reside in endemic areas. The drugmaker plans to launch Dengvaxia early next year.
"Today, with this first marketing authorisation of Dengvaxia, we have achieved our goal of making dengue the next vaccine-preventable disease," remarked Sanofi CEO Olivier Brandicourt, adding "this is a historic milestone for our company, for the global public health community and, most importantly, for half the world’s population who lives at risk of dengue."
According to the French drugmaker, approval of Dengvaxia in Mexico was supported by a clinical development programme involving more than 40 000 people of different ages, geographic and epidemiological settings and ethnic and socio-economic backgrounds in 15 countries. Sanofi noted that dengue-endemic regions of Mexico participated in all three phases of the clinical development programme for the vaccine.
Phase III study data reported in July 2014 showed the vaccine cut the number of symptomatic virologically-confirmed cases of dengue from any serotype by 56.5 percent. However, data indicated that the vaccine offered less protection for young children and was less effective against dengue serotype 2, offering only 35-percent protection. Meanwhile, results of a second late-stage study demonstrated that the vaccine led to an overall reduction of dengue cases by 60.8 percent.
Sanofi Pasteur CEO Olivier Charmeil said that the company has yet to agree upon a price with the Mexican government but expects to do so in coming weeks. Charmeil explained that the price of the vaccine would reflect savings generated elsewhere, noting that the annual cost of treating dengue is about $9 billion globally while prevention strategies such as mosquito nets add an additional $6 billion to $9 billion. Analysts estimated that the vaccine could generate $1.4 billion in revenue by 2020.
Charmeil added that the drugmaker will have submitted Dengvaxia for approval in 20 of the countries where it is most widespread by the end of the year, with additional approvals anticipated in the coming weeks. The executive said that Sanofi plans to submit the vaccine for European approval in 2016 and approval in the US the following year.
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