Sanofi's Dengue Vaccine Gets FDA Approval -- Update

Date : 05/02/2019 @ 3:16AM
Source : Dow Jones News
Stock : Sanofi (SAN)
Quote : 75.98  0.0 (0.00%) @ 4:39PM
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Sanofi's Dengue Vaccine Gets FDA Approval -- Update

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By Maria Armental 

Sanofi SA's dengue vaccine was approved in the U.S., the first treatment cleared by American regulators to protect against the mosquito-borne viral infection.

The vaccine, Dengvaxia, was approved by the Food and Drug Administration to treat people aged 9 to 16 with a laboratory-confirmed prior infection who live in areas where the disease occurs regularly through the year.

Dengvaxia was first approved in Mexico in 2015 and remains the world's only approved vaccine against dengue. But safety fears have complicated efforts to contain the growing global threat. World Health Organization estimates put about half the world's population at risk.

In late 2017, Sanofi said post-marketing data showed those who haven't been infected before may have a higher risk of severe dengue disease if they become infected after vaccination.

The Philippines, which was the first country to widely distribute the vaccine, revoked its product-license approval this year after a number of deaths were reported.

The virus causes a severe flu-like illness, but it can develop into severe dengue, which is potentially deadly. It is typically found in tropical and sub-tropical climates.

Though not common in the U.S., several U.S. territories are prone to outbreaks, including Puerto Rico, the U.S. Virgin Islands, American Samoa and Guam.

The disease is hard to vaccinate against because it can be caused by four strains of the same virus. Dengvaxia targets the four strains.

Other vaccines are being developed, including Takeda Pharmaceutical Co.'s TAK-003, which has shown promising results in a key trial.

Write to Maria Armental at maria.armental@wsj.com

 

(END) Dow Jones Newswires

May 01, 2019 22:01 ET (02:01 GMT)

Copyright (c) 2019 Dow Jones & Company, Inc.
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