Sanofi gets Priority Review for dengue vaccine

Sanofi (Euronext:SAN; NYSE:SNY) said FDA accepted and granted Priority Review to a BLA for Dengvaxia dengue tetravalent vaccine. The PDUFA date is May 1, 2019. If approved, Dengvaxia "would represent the first and only medical prevention tool against dengue" in the U.S., according to Sanofi.

The announcement comes less than two weeks after EMA’s CHMP recommended approval of Dengvaxia to prevent dengue disease caused by dengue virus serotypes 1, 2, 3 and 4 in people ages 9 to 45 who are living in an endemic area and who already had a prior dengue virus infection. Sanofi expects a decision from the European Commission in December...