Sanofi loses appeal to restore Dengvaxia registration: DOH


Posted at Aug 22 2019 12:10 PM | Updated as of Aug 22 2019 03:06 PM

MANILA (UPDATE) - The Department of Health said Thursday it denied the appeal of French drug maker Sanofi Pasteur to reverse a regulatory ruling that effectively banned the use of its anti-dengue vaccine in the Philippines.

The DOH said it upheld the permanent revocation of the certificate of product registration for Dengvaxia for "continued failure to submit post-approval requirements."

"The decision concerns Sanofi’s complete disregard of FDA regulations, which were precisely put in place by law to ensure safety,” Health Secretary Francisco Duque said. The decision was dated Aug. 19.

Sanofi may reapply for a new certificate of registration at the FDA, according to the DOH as it said the agency was "focusing" on its response to the national dengue epidemic.

Sanofi said it would "thoroughly study all possible remedies available to us under Philippine laws and regulations while keeping in mind the best interest of the Filipinos."

While the firm said it "respectfully disagrees" with the violations cited by the DOH, Sanofi said it was grateful to the agency for "recognizing that the safety of Dengvaxia is not on trial" and the "dire need" for a dengue vaccine in the market.

Sanofi failed to submit the third and final risk management plan or RMP for the drug, which was recalled in late 2017 due to safety concerns, the DOH said.

"Given that Dengvaxia is an innovative drug, the importance of complying with these post-marketing commitments is critical to public safety," it said.

The Dengue Vaccine National Expert Panel urged Sanofi to submit its updated data on pharmacovigilance and post-marketing surveillance, the DOH said.

"This should show what the company has done in terms of monitoring and preventing the drug’s adverse effects for the more than 830,000 individuals vaccinated," it said.