SK Biopharm has submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) to expand the indication of its epilepsy drug, cenobamate (marketed in the U.S. as Xcopri), to include generalized tonic-clonic seizures. This move aims to broaden the treatment scope from adult focal seizures to encompass patients with generalized seizures.
On November 3, SK Biopharm announced that it submitted the sNDA for cenobamate to target patients aged 12 and older with primary generalized tonic-clonic seizures (PGTC).
PGTC is a type of generalized seizure that involves both sides of the brain from the onset. It is characterized by a stiffening phase where the patient loses consciousness, followed by a clonic phase where the limbs shake repeatedly.
The application is based on the results of a global Phase 3 clinical trial (NCT03678753) announced in September of last year. The trial was conducted across 122 sites in 12 countries, including the U.S., South Korea, and Europe, involving 169 patients aged 12 and older with PGTC. The results showed that the frequency of PGTC seizures in the cenobamate group decreased by a median of 71.9% compared to baseline, while the placebo group saw a 39.6% reduction, indicating a significant difference between the two groups.
Most adverse events reported during the safety evaluation were mild to moderate and consistent with the existing safety profile of cenobamate. No new safety issues were observed.
If approved by the FDA, cenobamate's treatment indications will expand to include PGTC in addition to the existing focal seizures (FOS). SK Biopharm plans to provide more treatment options for a wider range of epilepsy patients and enhance the growth potential of the product.
In October, SK Biopharm submitted an sNDA to the FDA to expand the indication for adult focal seizures to include pediatric patients. Earlier in March, the company also submitted a new drug application (NDA) for cenobamate oral suspension.
Since its U.S. launch in 2020, the company has been managing cenobamate's lifecycle through three main strategies: expanding the prescribing age, adding new indications, and diversifying formulations.
Lee Dong-hoon, CEO of SK Biopharm, stated, "This application for the PGTC indication is a turning point that goes beyond expanding the treatment target and broadens the long-term growth trajectory of the product. Through lifecycle management strategies, we aim to provide more treatment options for patients and enhance our global competitiveness."
* This article has been translated by AI.
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