FDA Advisory Panel Gives Mixed Review to Sanofi’s Dengue Vaccine

Sanofi has been hoping to secure approval from the U.S. Food and Drug Administration (FDA) for its dengue vaccine, but a mixed review from a panel of experts could sink the chances of a green light for the medication. The FDA is expected to rule on Sanofi’s Biologics License Application by May 1 but if an advisory review of the medication is an indication, the FDA may dash Sanofi’s hope for a blockbuster vaccine. On Thursday, the FDA advisory panel handed down a split decision on both the safety and efficacy of the vaccine, which would be sold under the trade name Dengvaxia. The panel voted six to seven on efficacy when it came to the target population of the drug, patients ages 9 to 45 years old. There was one abstention. On safety, the panel was evenly split at 7 to 7. When it came to a smaller group of patients, those ages 9 to 17, the advisory panel was more supportive of the treatment, voting 13 to 1 in support of the vaccine’s efficacy and 10 to 4 on safety. The FDA granted a priority review for Dengvaxia. In December, Dengvaxia, a live recombinant tetravalent dengue vaccine, snagged regulatory approval in Europe. It was first approved in 2015. Dengvaxia will be available in Europe to prevent dengue disease in individuals 9-45 years of age with a documented prior dengue infection and who are living in endemic areas, the company announced in December.