FINTEPLA® (fenfluramine) oral solution launched in the U.S. in late July for Dravet syndrome with high enrollment of physicians and patients into the FINTEPLA Risk Evaluation and Mitigation Strategy (REMS) program
More than 300 patients prescribed FINTEPLA and enrolled in the FINTEPLA REMS program in the third quarter; over half of the patients were new to FINTEPLA
Received a positive opinion from the Committee for Medicinal Products for Human Use for FINTEPLA in Dravet syndrome; European approval of the Marketing Authorization Application anticipated by the end of 2020
Announced highly positive top-line results from third Phase 3 trial of FINTEPLA in Dravet syndrome (Study 3) to support a planned submission of a Japan New Drug Application in the third quarter of 2021
Ended the third quarter with $525 million in cash, cash equivalents, and marketable securities
#ZGNX "announced financial results for the three and nine months ended September 30, 2020 and provided a corporate update. The Company will host a conference call today, Monday, November 9, at 4:30 PM Eastern Time/1:30 PM Pacific Time.
FINTEPLA for the treatment of seizures associated with Dravet syndrome: ° Received FDA approval on June 25, 2020 and initiated U.S.commercial launch on July 27, 2020 ° More than 360 prescribers had successfully completed Risk Evaluation and Mitigation Strategy (REMS) certification process by the end of September ° During the third quarter, more than 300 patients were prescribed FINTEPLA and enrolled in the FINTEPLA REMS program to become eligible to receive therapy, with approximately 90% completing echocardiograms. More than half of these patients were new to FINTEPLA. ° Received positive CHMP opinion in October 2020 for FINTEPLA in Dravet syndrome; anticipate European Medicines Agency approval by the end of 2020, and have ramped up preparations for a potential commercial launch in Europe in the first quarter of 2021 ° Announced positive top-line results from third multinational (including Japan) Phase 3 study in Dravet syndrome; results corroborate highly statistically significant reductions in convulsive seizure frequency seen in two earlier Phase 3 studies of FINTEPLA in Dravet. Anticipate submission of a Japan NDA to Japan’s Pharmaceutical and Medical Devices Agency in the third quarter of 2021
FINTEPLA for the treatment of seizures associated with LGS: ° Anticipate submitting supplemental NDA in the second quarter of 2021 following a successful Type C meeting in September clarifying regulatory path ° Anticipate submitting MAA with EMA in the third quarter of 2021
MT1621 for the treatment of TK2d: ° Recently held positive FDA meetings to discuss development path and data required to support planned NDA submission ° Company expects availability of all required data by end of 2021, and anticipates the submission of an NDA in first half of 2022
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