u200cFDA批准苯巴那酯(cenobamate)用于治疗成人部分性癫痫

On November 21, 2019, PANGYO, South Korea and PARAMUS, New Jersey, United States - SK Biopharmaceuticals Co., Ltd., an innovative global pharmaceutical company focusing on the treatment of central nervous system (CNS) diseases, and its U.S. subsidiary SK Life Science, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved it for the treatment of partial-onset epilepsy in adults.

Expert Comments‌

Dr. Michael Sperling, director of the Jefferson Comprehensive Epilepsy Center at the Vickie and Jack Farber Neuroscience Institute at Jefferson Health in Philadelphia and an investigator on the cenobamate clinical development project, said: "The approval of cenobamate will provide clinicians with an effective drug. For the treatment of patients with persistent focal (partial-onset) epilepsy. Encouragingly, patients treated with cenobamate experienced a significant reduction in seizure frequency, and some patients even achieved zero seizures."

Clinical Study Basis‌

The approval was based on the results of two global, randomized, double-blind, placebo-controlled studies (Study 013 and Study 017) and a large global, multicenter, open-label safety study. These studies included adults with uncontrolled partial-onset epilepsy taking 1 to 3 concomitant antiepileptic drugs (AEDs). In randomized studies, cenobamate showed a greater reduction in seizure frequency than placebo at all doses studied.

Patient needs and market significance‌

Approximately 3 million adults in the United States suffer from epilepsy, and according to the Centers for Disease Control and Prevention (CDC), nearly 60% of patients report seizures even while taking AEDs. Beth Lewin Dean, CEO of the epilepsy research organization CURE, said: "There is an urgent need to advance research and introduce new treatment options. The FDA approval of cenobamate for the treatment of partial-onset epilepsy is a welcome option for the epilepsy patient community."

This approval marks the first time that a Korean company has independently brought a compound from the discovery stage to the U.S. FDA approval stage. Dr. Jeong Woo Cho, President and CEO of SK Biopharmaceuticals and SK Life Science, said: "Today's approval is an important step in our journey to become a fully integrated global pharmaceutical company capable of discovering, developing and delivering new treatment options for epilepsy and the CNS. Take one step. ”

Safety Warning‌

Cenobamate may cause the following serious reactions: drug reaction with eosinophilia and systemic symptoms (DRESS), QT interval shortening, suicidal behavior and ideation, and neurological adverse reactions. The most common (≥10% and higher than placebo) treatment-related adverse events included somnolence (drowsiness), dizziness, fatigue, diplopia (double vision), and headache.

Cenobamate is expected to be available in the United States in the second quarter of 2020, subject to completion of program review by the U.S. Drug Enforcement Administration (DEA) (usually within 90 days of FDA approval). SKLifeScience is committed to supporting patients using cenobamate and will launch a new patient assistance program to help patients initiate and adhere to treatment.