Sanofi set off an uproar in the Philippines with its 2017 disclosure that dengue shot Dengvaxia can cause more serious infections in some cases. Now, after investigations and more, the country’s FDA has permanently revoked the vaccine’s marketing license.
Citing “brazen defiance” from the drugmaker and saying Sanofi failed to meet its postmarketing requirements, the Philippines FDA pulled Dengvaxia’s regulatory approval, Reuters reports.
The decision may not come as a surprise to market watchers, considering the tough stance officials in the Philippines took after Sanofi’s safety disclosure back at the end of 2017. The company said new trial analyses showed its vaccine can cause more serious infections if given to people who haven’t been infected with dengue before. The disclosure triggered a controversy. Officials immediately called off a vaccination campaign, demanded a refund and kicked off investigations.
Now, in the face of this week's regulatory move, Sanofi says it “respectfully disagrees” with the FDA’s conclusions and has filed a motion for reconsideration. Despite the controversy in the Philippines, the company is pressing ahead with its vaccine and is seeking European and U.S. approvals.
The news comes as a potential rival to Dengvaxia advances through testing. Takeda’s TAK-003 recently hit its efficacy mark in a massive phase 3 trial, and the Japanese drugmaker is awaiting a second set of data that will complete its filing for initial regulatory approvals. Takeda plans to seek marketing OKs in endemic countries before the U.S. and Europe, a company official told Reuters, which would follow Sanofi’s strategy with Dengvaxia.
But Sanofi’s vaccine head, David Loew, recently told FiercePharma that the company erred in putting EU and U.S. filings behind applications in emerging countries. That's because other regulatory authorities often look to the FDA and EMA for their own guidelines, so launching without U.S. and European approvals was harder than Sanofi expected.
Dengvaxia initially carried blockbuster sales expectations, but the launch never took off commercially and ran into controversy early on with Sanofi’s safety disclosure. Now, the drugmaker is working to develop a diagnostic that would aid with future attempts to market the vaccine.