SK Life Science, Inc. Receives US FDA Approval for cenobamate tablets for the Treatment of Partial-Onset Seizures in Adults with Epilepsy

-    Approval based on pivotal trials that assessed the efficacy and safety of cenobamate

-    Arvelle Therapeutics has exclusive rights to develop and commercialize cenobamate in Europe

-    Arvelle Therapeutics plans to submit a Marketing Authorization Application in Europe in H1 2020 

Zug, Switzerland, November 25, 2019 - Arvelle Therapeutics GmbH, an emerging biopharmaceutical company focused on bringing innovative treatments to patients suffering from CNS disorders, announced that SK Life Science, Inc., a subsidiary of SK Biopharmaceuticals Co., Ltd., has received approval from the U.S. Food and Drug Administration (FDA) for cenobamate tablets, as a treatment for partial-onset seizures in adults (now referred to as focal-onset seizures), pending scheduling review by U.S. Drug Enforcement Administration (DEA).

Arvelle Therapeutics has licensed exclusive rights to develop and commercialize cenobamate in Europe from SK Biopharmaceuticals. Arvelle Therapeutics intends to file a Marketing Authorization Application (MAA) for cenobamate in EU as a treatment for focal-onset seizures in adult patients in H1 2020 based on the data generated from SK life science’s global clinical trial program, involving more than 1,900 patients across the Phase 2 and 3 trials.

The US approval is based on results from two randomized, double-blind, placebo-controlled studies and a large, international, multi-centre open-label safety study investigating cenobamate as an adjunctive therapy in adult patients with focal-onset seizures.^1-3 In the randomized studies (studies 013¹ and 017²), cenobamate demonstrated significant reductions in seizure frequency at all doses studied compared to placebo when each was added to 1 to 3 background anti-epileptic drugs.  Additionally, a statistically significant number of patients showed 50% or greater reduction in seizure frequency, and some patients achieved zero seizures.^1,2

In Study 013, which included a 6-week titration phase followed by a 6-week maintenance phase, a statistically significant 56% reduction from baseline in seizure frequency was seen with cenobamate 200 mg/day versus a 22% reduction with placebo over the 12-week double-blind period.¹ In Study 017, which included a 6-week titration phase followed by a 12-week maintenance phase, patients randomized to cenobamate 100 mg/day, 200 mg/day or 400 mg/day showed statistically significant responder rates  (≥50% reduction from baseline in seizure frequency), 40%, 56% and 64% respectively, versus a 25% reduction with placebo.²

During the maintenance phase of Study 013, a post-hoc analysis showed that 28% of patients receiving cenobamate had zero seizures, compared with 9% of placebo patients.¹ During the maintenance phase of Study 017, 4% of patients in the cenobamate 100 mg/day group, 11% of patients in the cenobamate 200 mg/day group, 21% of patients in the cenobamate 400 mg/day group and 1% of patients in the placebo group reported zero seizures.²

The most frequent adverse events reported across all studies (>10%) were somnolence, dizziness, diplopia, fatigue and headache. Throughout the entire clinical development program three serious cases of drug reaction with eosinophilia and systemic symptoms (DRESS) occurred. Throughout the open label safety study with over 1300 patients (study 021), which included a lower starting dose and slower titration, there were no cases of DRESS observed.³

Mark Altmeyer, President and CEO of Arvelle Therapeutics said: “The FDA approval for cenobamate is a critical step forward in our efforts to bring this important potential medicine to Europe for individuals with epilepsy experiencing uncontrolled seizures.  Arvelle Therapeutics has exclusive European rights to cenobamate and is working to finalize the EU Marketing Authorization Application. We believe cenobamate could potentially be a welcome new treatment option for people living with this debilitating condition.”

There are an estimated six million people in Europe with epilepsy⁴ and approximately 40% of adult patients with epilepsy have inadequate control of seizures after treatment with two AED regimens.5,6

Prof. Steinhoff, a leading epileptologist from the Kork Epilepsy Center in Kehl-Kork, Germany mentioned: “I am very pleased with the US approval of cenobamate for the treatment of epilepsy patients with focal-onset seizures. This is certainly an important validation step in the journey to bring cenobamate to European patients.  This approval, coupled with our own experience with the drug, makes me very excited about the prospect of having access to this new therapeutic option.”

Further information can be found in the press release issued by SK Biopharmaceuticals and SK life science on November 21, 2019.