Sanofi may seek U.S. approval for Dengvaxia despite Philippines outrage

PARIS (Reuters) - Sanofi will decide shortly whether to seek regulatory approval for its dengue vaccine Dengvaxia in the United States and remains committed to the medicine despite a health scare in the Philippines, a senior executive said on Wednesday.

David Loew, head of Sanofi Pasteur, the French drugmaker’s vaccines division, said his teams had complied with all regulations regarding Dengvaxia and had no regrets about the way the product had been developed.

The Philippines, where more than 800,000 school-age children were vaccinated in 2016, suspended a vast public immunization program last year because of safety concerns.

Sanofi warned in November that the use of Dengvaxia was to be limited due to evidence it can worsen the disease in people who have not previously been exposed to the infection.

In February, a Philippine government agency filed a lawsuit against Sanofi, demanding compensation for the parents of a 10-year-old girl who the agency said had died as a result of receiving Dengvaxia.

Sanofi has repeatedly said it knew of no deaths resulting from the vaccine. While some experts have said the company and regulators might have ignored warnings about how the vaccine was developed, executives at Sanofi deny any wrongdoing.

“On the whole path of development, we always worked with the World Health Organization (WHO) and experts in the dengue community. We were always transparent,” Loew told Reuters in an interview, referring to the WHO and other regulators.

“You need to ask yourself: what was done with the information that was available at the time? Looking back, I would say no, we would not have done anything differently.”

Mosquito-borne dengue is the world’s fastest-growing infectious disease, afflicting up to 100 million people worldwide. It causes half a million life-threatening infections and kills about 20,000 people, mostly children, each year.

Loew said the company would decide within two months whether to make a regulatory filing for Dengvaxia with the U.S. Food and Drug Administration.

He also said Sanofi was holding discussions with external partners and universities to come up with a test which would be applicable before vaccination. Such a test would take at least two years to bring to the market.

“We operate in environments where the temperature is 30-40 degrees Celsius so you want to be sure that the tests resist (...) If you have a vaccination campaign taking place in a school for example, you want to make sure it is ‘implementable,’” he said.

Dengvaxia has been approved and registered in 19 countries so far, mostly in the developing world. It is currently under review by the European Medicines Agency.

Sanofi booked an impairment charge of 87 million euros ($108 million) related to Dengvaxia in its fourth-quarter results.

Loew said the prospect of another financial charge this year was “extremely low.”

($1 = 0.8069 euros)

MARCH 7, 2018

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