- 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.
For more information please contact:
Head of Marketing
Consilium Strategic Communications (international strategic communications)
Mary-Jane Elliott/Susan Stuart/Alex Harrison/Lindsey Neville
Telephone: +44 (0)20 3709 5700
About Arvelle Therapeutics
Arvelle Therapeutics is an emerging biopharmaceutical company focused on bringing innovative solutions to patients suffering from CNS disorders. Arvelle is responsible for the development and commercialization of cenobamate, an investigational antiepileptic drug, in the European market. Arvelle is headquartered in Switzerland and received start-up financing of $207.5 million, one of the largest initial financing commitments for a European-‐focused biopharmaceutical company, with investments from a global syndicate including NovaQuest Capital Management, BRV Capital Management, LSP, H.I.G. BioHealth Partners, Andera Partners, F-Prime Capital and KB Investments. More information is available at http://Arvelletx.com.
Arvelle Therapeutics has licensed exclusive rights to develop and commercialize cenobamate in Europe. Arvelle Therapeutics intends to file a Marketing Authorization Application (MAA) in the EU for cenobamate as a treatment for focal-onset seizures in adult patients based on the data generated from SK Biopharmaceuticals’ global clinical trial program, involving more than 1,900 patients.
About SK Biopharmaceuticals, Co., Ltd. and SK Life Science, Inc.
SK Biopharmaceuticals and its U.S. subsidiary SK life science are focused on the research, development and commercialization of treatments for disorders of central nervous system (CNS). Additionally, SK Biopharmaceuticals is focused on early research and development in oncology. Both are part of SK Group, one of the largest conglomerates in Korea.
SK Holdings continues to enhance its portfolio value by executing long-term investments with a number of competitive subsidiaries in various business areas, including pharmaceuticals and life science, energy and chemicals, information and telecommunication, and semiconductors. In addition, SK Holdings is focused on reinforcing its growth foundations through profitable and practical management based on financial stability, while raising its enterprise value by investing in new future growth businesses. For more information, please visit http://hc.sk.co.kr/en/.
Currently, SK Biopharmaceuticals is conducting basic research for the development of innovative new therapies at its research center in Pangyo, Gyeonggi Province, Korea. SK life science, based in Paramus, New Jersey, is pursuing clinical development and the U.S. commercialization of cenobamate.
The companies have a pipeline of eight compounds in development for the treatment of CNS disorders including epilepsy, Lennox-Gastaut syndrome and attention deficit hyperactivity disorder, among others. For more information, visit SK Biopharmaceuticals’ website at www.skbp.com/eng and SK life science’s website at www.SKLifeScienceInc.com.
Cenobamate was discovered by SK Biopharmaceuticals and SK life science and is a new FDA-approved anti-epileptic drug (AED) for the treatment of partial-onset seizures in adults. Cenobamate will be available in the U.S. pending review by the U.S. Drug Enforcement Administration (DEA) in 2020. In early 2019, SK Biopharmaceuticals entered into an exclusive licensing agreement with Arvelle Therapeutics to develop and commercialize cenobamate in Europe.
Cenobamate is believed to reduce repetitive neuronal firing by inhibiting voltage-gated sodium currents and as a positive allosteric modulator of the GABAA ion channel. Cenobamate can be combined with other AEDs or used alone.
Global trials for adults with partial-onset seizures are ongoing to evaluate cenobamate’s long-term safety and additional clinical trials are investigating cenobamate in other seizure types.
- Chung SS et al. Epilepsy Curr 2014; 14(suppl 1): 438. Abstract 3.306.
- Krauss GL et al. Lancet Neurol. 2019; (published online Nov 13). https://doi.org/10.1016/S1474-4422(19)30399-0
- Sperling MR et al. American Epilepsy Society Annual Meeting, November 30 – December 4, 2018, New Orleans, LA, USA. Abstract 1.303. https://www.aesnet.org/meetings_events/annual_meeting_abstracts/view/500991.
- Epilepsy Alliance Europe. Background information. https://www.epilepsyallianceeurope.org/about/background/
- Kwan P and Brodie MJ. N Engl J Med. 2000;342(5):314-319.
- Chen Z et al. JAMA Neurol. 2018 Mar 1;75(3):279-286.