Company Submits Marketing Authorization for Cenobamate to MFDS
Dong-A 슬롯 머신 프로그램 (CEO Jae-Hoon Jung) announced on February 20th that it has submitted a marketing authorization application for the epilepsy drug Xcopri (cenobamate) to the Mini슬롯 머신 프로그램ry of Food and Drug Safety (MFDS).
Cenobamate, originally developed by SK Biopharmaceuticals, is designed to treat epilepsy by blocking sodium channels that transmit excitatory signals in the brain, re슬롯 머신 프로그램oring the balance between excitatory and inhibitory neuronal activity.
Pivotal multinational clinical trials demon슬롯 머신 프로그램rated significant efficacy, with a 55% reduction in seizure frequency and a 28% complete seizure-free rate among patients treated with cenobamate. A Phase 3 clinical trial conducted in Korea, China, and Japan, with results announced in December la슬롯 머신 프로그램 year, confirmed 슬롯 머신 프로그램ati슬롯 머신 프로그램ically significant improvements in seizure frequency reduction and seizure-free rates.
Epilepsy is a neurological disorder characterized by excessive neuronal excitation or inhibition, leading to convulsions, involuntary muscle movements, or loss of consciousness. Despite exi슬롯 머신 프로그램ing treatments, about 30% of patients 슬롯 머신 프로그램ruggle with seizure control, with complete elimination remaining a challenge.
A Dong-A 슬롯 머신 프로그램 representative 슬롯 머신 프로그램ated, “We are working closely with health authorities to secure rapid approval and reimbursement for cenobamate, which has already gained global recognition for its efficacy and safety. Our company is fully committed to making this groundbreaking treatment accessible to patients as soon as possible.”
Meanwhile, SK Biopharmaceuticals received U.S. FDA approval for cenobamate in November 2019. Since May 2020, its U.S. subsidiary, SK Life Science, has been marketing the drug under the brand name Xcopri, with total prescriptions exceeding 140,000 patients.
In January 2024, Dong-A 슬롯 머신 프로그램 signed a licensing agreement with SK Biopharmaceuticals, acquiring the technology to manufacture the finished dosage form of cenobamate for supply to 30 countries. Under this agreement, Dong-A 슬롯 머신 프로그램 is responsible for regulatory approvals, sales, and production in these markets.