SK Biopharmaceuticals has submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) on Tuesday to expand the treatment indication for its groundbreaking epilepsy medication, Cenobamate (marketed in the U.S. as Xcopri). The company aims to include primary generalized tonic-clonic seizures (PGTC) in patients aged 12 and older.

PGTC seizures are a form of generalized seizure that affects both hemispheres of the brain from the onset. Patients typically experience a tonic phase, characterized by loss of consciousness and muscle stiffening, followed by a clonic phase, marked by rhythmic jerking of the limbs.

The application is supported by encouraging results from a global Phase 3 clinical trial (NCT03678753) disclosed in September last year. The study involved 169 PGTC patients aged 12 and older across 122 clinical sites in 12 countries, including the United States, South Korea, and several European nations.

The trial results revealed a significant reduction in PGTC seizure frequency. The Cenobamate treatment group experienced a median decrease of 71.9% compared to baseline, while the placebo group showed a 39.6% reduction. This difference was statistically significant.

Safety assessments indicated that most reported adverse events were mild to moderate and aligned with Cenobamate's established safety profile. No new safety concerns emerged, and the drug demonstrated a generally favorable safety and tolerability profile.

If approved by the FDA, SK Biopharmaceuticals anticipates that expanding Cenobamate's treatment indication from focal onset seizures (FOS) to include PGTC will offer new therapeutic options for a broader range of epilepsy patients. The company also plans to bolster Cenobamate's long-term growth potential by widening its target patient demographic.

In October, SK Biopharmaceuticals submitted an sNDA to the FDA to extend the existing indication for adult focal seizures to include pediatric focal seizures. Earlier in March, the company filed a new drug application (NDA) for a Cenobamate oral suspension (OS) formulation.

Since Cenobamate's U.S. launch in 2020, SK Biopharmaceuticals has been implementing a comprehensive lifecycle management strategy. This approach focuses on three key areas: broadening the prescribing age range to include pediatric focal seizures, introducing new indications such as PGTC, and diversifying drug formulations with options like oral suspension.

Lee Dong-Hoon, Chief Executive Officer (CEO) of SK Biopharmaceuticals, stated that this application for the PGTC indication represents a pivotal moment in Cenobamate's development. It not only expands the treatment scope but also sets the stage for long-term growth. Through the strategic lifecycle management, it aims to provide more patients with access to this innovative treatment while strengthening Cenobamate's position in the global market.

SK Biopharmaceuticals has submitted a supplemental new drug application (sNDA) to the U.S. …

SK Biopharmaceuticals Seeks FDA Approval to Expand Cenobamate’s Indication to PGTC Seizures: A New Hope for Epilepsy Treatment?