Following a Type A meeting with the FDA, Zogenix (NASDAQ:ZGNX) reported that it plans to resubmit its NDA for FINTEPLA for the treatment of seizures associated with Dravet syndrome.
The meeting addressed two issues in the FDA’s April 5, 2019 refusal-to-file letter, and based on the final meeting minutes Zogenix received, the FDA has agreed to the company’s plan to resubmit the NDA for FINTEPLA.
“We now have the clarity required to successfully resubmit our FINTEPLA NDA, which we anticipate will occur in the third quarter [of 2019],” Stephen Farr, Zogenix’s president and CEO, said in a statement.
Zogenix also reported that the FDA has rescinded FINTEPLA’s breakthrough therapy designation for the treatment of seizures associated with Dravet syndrome as there are now two approved therapies for the disease: Biocodex’s DIACOMIT and Greenwich Pharmaceuticals’ EPIDIOLEX.
