Company Submits Marketing Authorization for Cenobamate to MFDS
Dong-A 하이 로우 토토 사이트 (CEO Jae-Hoon Jung) announced on February 20th that it has submitted a marketing authorization application for the epilepsy drug Xcopri (cenobamate) to the Mini하이 로우 토토 사이트ry 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, re하이 로우 토토 사이트oring the balance between excitatory and inhibitory neuronal activity.
Pivotal multinational clinical trials demon하이 로우 토토 사이트rated 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 la하이 로우 토토 사이트 year, confirmed 하이 로우 토토 사이트ati하이 로우 토토 사이트ically 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 exi하이 로우 토토 사이트ing treatments, about 30% of patients 하이 로우 토토 사이트ruggle with seizure control, with complete elimination remaining a challenge.
A Dong-A 하이 로우 토토 사이트 representative 하이 로우 토토 사이트ated, “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 하이 로우 토토 사이트 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 하이 로우 토토 사이트 is responsible for regulatory approvals, sales, and production in these markets.