Sanofi sparked an uproar in the Philippines, revealing in 2017 that dengue fever caused by dengue fever could lead to more serious infections in some cases. Now, after investigations and more, the country's FDA has definitely revoked the marketing license for the vaccine.
Citing the drug maker as "a shameless challenge" and claiming that Sanofi had not met its post-marketing requirements, the FDA of the Philippines has obtained regulatory approval from Dengvaxia, reports Reuters.
This decision may not surprise market observers, given the tough position adopted by the Philippine authorities following the release of Sanofi's safety data at the end of 2017. The company said that new tests will be conducted. show that his vaccine can cause more serious infections if administered to people. who have not been infected with dengue fever before. The disclosure sparked controversy. Officials immediately canceled a vaccination campaign, demanded reimbursement and opened investigations.
Today, faced with this week's regulatory decision, Sanofi "respectfully disagrees" with the FDA's findings and has filed a motion for reconsideration. Despite the controversy in the Philippines, the company is continuing to develop its vaccine and is seeking approval from Europeans and the United States.
RELATED: Sanofi dengue fever, Dengvaxia, wins FDA priority review despite controversial past
This news comes as Dengvaxia's potential rival progresses through the tests. Takeda's TAK-003 has recently reached its level of effectiveness during a large phase 3 trial, and the Japanese drug maker is expecting a second set of data that will complement its filing for initial regulatory approvals . Takeda plans to seek business alliances with endemic countries before the United States and Europe, a company official told Reuters, which would follow Sanofi's strategy with Dengvaxia.
RELATED: Takeda's shot against Sanofi's dengvaxia and its goal in the large phase 3 study
However, David Loew, vaccine manager at Sanofi, recently told FiercePharma that the company had made a mistake by placing EU and US filings behind applications filed in emerging markets. This is because other regulators often turn to the FDA and the EMA to follow their own guidelines. As a result, launching without US and European approvals was more difficult than anticipated by Sanofi.
Dengvaxia initially had outstanding sales forecasts, but the launch never took off commercially and was quickly subject to controversy with Sanofi's safety statement. The manufacturer is currently preparing a diagnosis that will facilitate future attempts to market the vaccine.