- The Food and Drug Administration has cleared the first vaccine for dengue in the U.S. Yet the approval announced Wednesday could sharply limit the drug's commercial potential by restricting its use to a small fraction of the population.
- With the FDA's OK, Sanofi's Dengvaxia is now approved to treat adolescents aged 9 through 16. Prospective recipients will need a laboratory-confirmed previous dengue infection and must live in an dengue endemic area, which includes American Samoa, Guam, Puerto Rico and the U.S. Virgin Islands.
- The French pharma has yet to announced its launch plans, but expects to make the vaccine commercially available in 2020. Timing will align with recommendations from a Centers for Disease Control and Prevention advisory committee, a company spokesperson told BioPharma Dive. An initial launch price also hasn't been determined.
An FDA advisory committee recommended in March to not approve Dengvaxia for patients aged 9 to 45, but did vote in favor of the vaccine for 9- to 16-year-olds. The agency's decision aligned with those votes.
The approval was also tailored to include only children already infected with dengue.
"This is because in people who have not been infected with dengue virus, Dengvaxia appears to act like a first dengue infection — without actually infecting the person with wild-type dengue virus — such that a subsequent infection can result in severe dengue disease," the agency said in a May 1 statement.
Typically, the second infection carries serious consequences, such as severe dengue and dengue hemorrhagic fever. The FDA estimated that 95% of all severe and hospitalized cases of dengue come from a second virus infection.
Testing for that first infection remains a challenge for Sanofi. The pharma is looking at potential collaborations with diagnostics manufacturers to create a rapid point-of-care dengue test, according to Sanofi's annual report.
The U.S. approval follows a European thumbs up last December with similar restrictions, although a wider age range from 9 to 45.
The narrow U.S. indication seems to take into account Dengvaxia's controversial history.
The Philippines rolled out a massive vaccination campaign with Sanofi's drug in 2016 only to suspend the program in November 2017 due to safety concerns. Earlier this year, Philippine legal authorities said they have probable cause to indict multiple Sanofi employees and state health officials over deaths related to the vaccine's use.
Dengvaxia may also enjoy a limited run as the only approved dengue vaccine. Takeda is developing a competitor that yielded positive topline results earlier this year in a large Phase 3 study, which included dengue-naive individuals.
Sanofi picked up a Priority Review Voucher with the approval, which can either expedite another drug's review or be sold to a fellow drugmaker. In March, Biohaven Pharmaceuticals paid $105 million for such a voucher from GW Pharmaceuticals.