TOKYO • Sanofi’s controversial dengue vaccine was dealt another blow as the Philippines permanently banned the treatment, which set off a health scare in the country.
The country’s Food and Drug Administration (FDA) said the French drugmaker failed to submit post-approval documents required by regulators, according to a statement on Tuesday.
The vaccine wasn’t on sale in the Philippines, having already been suspended there for a year. Sanofi appealed the decision and said the regulator wasn’t questioning “the safety and efficacy of Dengvaxia”.
The vaccine brings in little revenue, and many analysts started discounting its contribution to Sanofi’s bottom line after researchers found it posed a risk to people who had never suffered from dengue — putting them at risk of a more severe infection if they got the shot. Takeda Pharmaceutical Co is making progress on a rival injection for dengue.
The Sanofi vaccine has been approved for use in several countries in Latin America and Asia. It received European Commi s s ion approval in December and is under priority review with the US FDA.
However, the drug has hit hurdles in getting into other countries, with local media repor t ing Malaysia is reviewing the vaccine.
Sanofi’s “brazen defiance of FDA’s directives and its continued failure to comply leaves us no other recourse,” Nela Charade G Puno, DG of the Philippines’ FDA, said in the statement. — Bloomberg