2:15 PM
Mar 08, 2019
 |  BC Extra  |  Company News

FDA panel does not back broad reach of Sanofi's dengue vaccine

Sanofi's dengue vaccine did not win the support of an FDA panel for its proposed population of individuals ages 9-45 Thursday, but the panel did back the vaccine's use in adolescents.

The vote came as Sanofi (Euronext:SAN; NASDAQ:SNY) employees and government officials in the Philippines face criminal charges related to the deaths of 10 children allegedly linked to the vaccine, Dengvaxia (see "Sanofi, Government Officials Face Criminal Charges in Philippines for Dengvaxia Deaths").

A series of long-term studies in 2017 found Dengvaxia exacerbated infection in some dengue-naïve or seronegative children. Sanofi took the findings into account in its BLA, which seeks Dengvaxia's approval in individuals with laboratory-confirmed previous dengue infection and living in endemic areas.

On Thursday, FDA's Vaccines and Related Biological Products Advisory Committee was deadlocked on the vaccine's risk-benefit profile in the proposed population, voting 6-7, with one abstention, that data support the vaccine's efficacy, and 7-7 that data support its safety in people ages 9-45.

For adolescents ages 9-16, the committee voted 13-1 in favor of Dengvaxia's efficacy profile and 10-4 in support of its safety profile.

The BLA is under Priority Review with a May 1 PDUFA date.

The European Commission approved Dengvaxia in December.

After Sanofi confirmed in 2017 the vaccine's performance differed according to prior dengue infection status, the French pharma subsequently proposed a label update to global regulatory authorities that asks healthcare professionals to assess the likelihood of prior dengue infection in an individual before vaccinating. For individuals who have not been previously infected by dengue virus, Sanofi said vaccination should not be recommended (see “Dengvaxia’s Warning”).

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