The U.S. Food and Drug Administration (FDA) extended by three months the review period for Zogenix’s New Drug Application (NDA) for Fintepla (ZX008), an investigational anti-seizure therapy for patients with Dravet syndrome.
The agency now expects to provide a decision by June 25 on whether to approve Fintepla for the treatment of seizures associated with Dravet.
The extension will allow the FDA more time to review additional data Zogenix submitted in response to a request from the agency. “The FDA determined that the submission of this information constituted a major amendment to the NDA,” Zogenix said.
The FDA refused Zogenix’s first NDA for Fintepla, submitted in April 2019, saying the company failed to include non-clinical studies addressing the chronic administration of active substance fenfluramine hydrochloride. The agency also said one of the clinical datasets included in the application was incorrect.
After a Type A meeting in May 2019, the FDA agreed to allow Zogenix to resubmit its application without including new chronic toxicity studies the agency had requested when it refused the first NDA. The FDA also agreed to allow Zogenix to resubmit the datasets.
Fintepla is a low-dose oral solution of fenfluramine hydrochloride. The therapy is given with other treatments to reduce the frequency of epileptic seizures.
The NDA for Fintepla was based on results from two Phase 3 clinical studies, ZX008-1501 (NCT02682927) and ZX008-1502 (NCT02826863), as well as from an interim analysis of an ongoing open-label extension study (NCT02823145).
Data from the two Phase 3 trials showed that when administered in combination with other antiepileptic medications, Fintepla lowered the monthly frequency of convulsive seizures in children and young adults with Dravet, when compared with a placebo.
Results from the open-label study, which included patients who completed one of the two previous Phase 3 studies, showed that Fintepla provided a sustained and meaningful decline in convulsive seizure frequency in young children with Dravet syndrome, with similar clinical efficacy to that seen in older patients.
“We remain very confident in the data supporting our NDA submission, and look forward to continuing discussions with the FDA during the review process,” Stephen J. Farr, PhD, president and CEO of Zogenix, said in a press release. “We are committed to bringing this investigational therapy forward to help meet the needs of patients and families with Dravet syndrome.”
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