New Drugs Approved In May


The FDA approved Dengvaxia, the first dengue vaccine, developed by Sanofi Pasteur, the vaccine division of Sanofi Inc. (SNY), on May 1, 2019, for the prevention of dengue disease caused by all dengue virus serotypes (1, 2, 3 and 4) in people ages 9 through 16 who have laboratory-confirmed previous dengue infection and who live in endemic areas.

Dengvaxia is a live, attenuated vaccine that is administered as three separate injections, with the initial dose followed by two additional shots given six and twelve months later.

The department of health in Philippines suspended Dengvaxia in 2017 when Sanofi published post marketing studies showing that the vaccine caused infection in children who have never had dengue infection before. The country completely banned the product in 2019.

The vaccine was approved by the European Medicines Agency in October 2018.