Sanofi announces FDA priority review granted for dengue vaccine

The FDA has accepted a biologics license application for Sanofi Pasteur’s dengue vaccine. The dengue vaccine candidate has been granted priority review by the FDA as it would represent the first and only medical prevention tool against dengue, including severe dengue, which is considered an unmet medical need. The FDA set a Prescription Drug User Fee Act action date of May 1. Dengue is endemic in the U.S. territories of Puerto Rico and the US Virgin Islands. In 2010, Puerto Rico experienced the largest outbreak when more than 12,000 cases were confirmed. Incidence remained high in subsequent years, particularly in 2012 and 2013. Dengue represents a health and economic burden in Puerto Rico with total annual associated costs reaching an estimated $160.2M. The vaccine, known as Dengvaxia in countries where it is approved, remains the only vaccine available for the prevention of dengue. The European Commission is expected to grant marketing authorization for Dengvaxia in December.
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