연합뉴스1 hour agoBusiness2 min readSouth Korea

SK Biopharm applies for additional indication for cenobamate to the U.S. FDA

Submission of sNDA for primary generalized tonic-clonic seizures over 12 years of age

Quick Look

SK Biopharm submitted an sNDA to the FDA to add the indication for primary generalized tonic-clonic seizures for ages 12 and older for its new epilepsy drug cenobamate.
As a result of the global phase 3 clinical trial, the frequency of seizures was statistically significantly reduced, and upon approval, the treatment area and target patient group will be expanded.

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Why It Matters

SK Biopharm has already submitted an sNDA to expand indications for pediatric partial seizures in October and an NDA for oral suspension in March. Cenobamate is sold in the United States under the product name Xcopri.

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SK Biopharm [326030] announced on the 4th that it has applied for additional new drug approval (sNDA) to the U.S. Food and Drug Administration (FDA) to expand the treatment area of its new epilepsy drug, cenobamate (US product name: Xcopri®).

The indication to be added is primary generalized tonic-clonic seizures (PGTC) in patients over 12 years of age.

This application was made based on the results of a global phase 3 clinical trial announced in September of last year.

At that time, clinical trials were conducted on 169 PGTC patients aged 12 or older at 122 clinical institutions in 12 countries, including the United States, Korea, and Europe.

Clinical results showed that the median PGTC seizure frequency decreased by 71.9% in the cenobamate group and 39.6% in the placebo group compared to the baseline, showing a statistically significant difference.

In the safety evaluation, most of the reported adverse events were mild to moderate and no new safety issues emerged.

If approved by the FDA, the treatment area of cenobamate will expand from the existing focus on partial seizures (FOS) to PGTC.

SK Biopharmaceuticals plans to strengthen the mid- to long-term growth basis for cenobamate by expanding the patient group eligible for treatment.

In October, the company submitted an sNDA to the FDA to expand the existing indication for partial seizures in adults to pediatric patients with partial seizures.

Also, in March, a new drug application (NDA) for cenobamate oral suspension was submitted to the FDA.

Lee Dong-hoon, CEO of SK Biopharmaceuticals, emphasized, “The application for the additional PGTC indication is a turning point that goes beyond expanding the treatment target of cenobamate and expands the product’s growth path,” and added, “We will provide treatment options to more patients and increase the global competitiveness of cenobamate through a life cycle management strategy that encompasses indications, age, and dosage form.”

What to Watch

AI outlook — possibilities, not facts

FDA will consider additional approval of cenobamate for PGTC indication
Likely · Within months

Open Questions

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SK Biopharm applies for additional indication for cenobamate to the U.S. FDA

Submission of sNDA for primary generalized tonic-clonic seizures over 12 years of age

Quick Look

SK Biopharm submitted an sNDA to the FDA to add the indication for primary generalized tonic-clonic seizures for ages 12 and older for its new epilepsy drug cenobamate.
As a result of the global phase 3 clinical trial, the frequency of seizures was statistically significantly reduced, and upon approval, the treatment area and target patient group will be expanded.