After Philippines safety scandal, Sanofi's Dengvaxia set for European approval

Sanofi's dengue vaccine woes cost the company €158 million last year. (Sanofi on Flickr)

Sanofi has had a rough time with its world-first dengue vaccine Dengvaxia, thanks to a safety controversy in the Philippines that hurt the drugmaker's bottom line last year. But the company isn’t giving up on the vaccine—and neither are regulators. 

The European Medicines Agency’s Committee for Medicinal Products for Human Use endorsed the vaccine to protect against dengue serotypes 1 through 4 for people aged 9 to 45 who have had a prior infection. 

The latter point is important, because Sanofi previously marketed Dengvaxia regardless of a patient’s dengue history but later found that the vaccine can cause more serious cases if given to those who haven’t had a prior infection. In the aftermath of that finding, the Philippines canceled future vaccine orders and demanded a refund from the company.

Sanofi ended up refunding the cost of unused doses and took an €87 million inventory charge. In total, the episode cost the company €158 million last year, the company said. 

RELATED: Sanofi takes €100M charge after Dengvaxia analysis leads it to seek smaller label 

The European Commission is expected to approve the vaccine in December, according to Sanofi.

After studying data on the vaccine, advisers for the World Health Organization determined in April that Dengvaxia should be used “exclusively or almost exclusively" in people who have had a diagnostic-confirmed prior infection, creating a significant hurdle for vaccination programs. A point-of-care test for the virus doesn’t yet exist, and could take years to develop, Sanofi has said.

RELATED: Sanofi's Dengvaxia needs a dengue diagnostic, stat, thanks to WHO  

In its first year, Sanofi execs said Dengvaxia could deliver sales of up to €200 million. Early expectations were for blockbuster sales. But in 2016, Dengvaxia's first year on the market, the vaccine generated sales of €55 million. In 2017, sales sank to €3 million. 

As Sanofi presses ahead with its vaccine, Takeda is testing a potential rival in phase 3.