Biopharmaceutical company Sanofi (EURONEXT:SAN) (NYSE:SNY) said on Tuesday that it has successfully filed its Biologics License Application for its dengue vaccine with the US Food and Drug Administration (FDA).
According to the company, the dengue vaccine candidate has been granted priority review by the US FDA as it would represent the first and only medical prevention tool against dengue, including severe dengue, which is considered an unmet medical need.
In conjunction with the filing, the US FDA has set a Prescription Drug User Fee Act action date of 1 May 2019.
The company stated that 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 authorisation for Dengvaxia in December 2018.
Dengue represents a health and economic burden in Puerto Rico with total annual associated costs reaching an estimated USD160.2m. People can get dengue up to four times and dengue is unique in that the second infection tends to be worse than the first.
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