Sanofi rebelled in the Philippines with its 2017 statement that dengue shot Dengvaxia may cause more serious infections in some cases. Now, after studies and more, the country's FDA has permanently lifted the marketing authorization of the vaccine.
Cited "brazine defiance" by drugmaker, saying that Sanofi did not meet its post-marketing requirements, the Philippines drew FDA Dengvaxia's regulatory approval, reports from Reuters.
The decision cannot come as a surprise to market viewers, as the hard attitude officials in the Philippines, according to Sanofi's security information, revealed at the end of 2017. The company said that new test analyzes showed that the vaccine could cause more serious infections if given to people who have not been infected with dengue before. The information triggered a controversy. Officials immediately interrupted a vaccination campaign, demanding reimbursement and completed examinations.
Based on this week's regulatory steps, Sanofi says it "respectfully disagrees" with the FDA's conclusions and has submitted a proposal for reconsideration. Despite the controversy in the Philippines, the company is pushing forward with its vaccine and seeking European and American approvals.
RELATED: Sanofi's dengue shot Dengvaxia wins FDA priority review despite controversial past
The news comes as a potential rival to Dengvaxia's progress through testing. Takeda's TAK-003 recently hit its efficiency mark in a massive phase 3 trial, and the Japanese drugmaker is awaiting another set of data that will complete its application for initial regulatory approval. Takeda plans to market OKS in endemic countries before the US and Europe, a company manager told Reuters who would follow Sanofi's strategy with Dengvaxia.
RELATED: Takeda & # 39; s dengue shot competing with Sanofi & # 39; s Dengvaxia hits the mark in massive phase 3 study
But Sanofi & # 39; s vaccine manager, David Loew, recently told FiercePharma, that the company has made a mistake by putting EU and US applications behind applications in emerging countries. This is because other regulatory authorities often look to the FDA and EMA for their own guidelines, so launching without US and European approvals was more difficult than Sanofi expected.
Originally, Dengvaxia had high expectations of sales, but the launch never took off commercially and ran into controversy early on with Sanofi's security information. Now the drugmaker is working to develop a diagnostic that will help with future attempts to market the vaccine.