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40200511000001106
New Medicines
Ontozry (EU), Xcopri (US) Partial focal epilepsy - adjunctive therapy
Information
Ontozry (EU), Xcopri (US)
New molecular entity
Arvelle Therapeutics
SK Bio-Pharmaceuticals
Development and Regulatory status
Launched
Launched
Launched
December 2021
Dec 21Available in the EU, as well as UK [18].
Dec 21The company was planning to make Ontozry available in December. NHS indicative price is £87.36 for 14 x 100mg tablets; £136.50 for 28 x 100mg tablets; £89.18 for 14 x 150mg tablets; £182 for 28 x 150mg tablets. 50mg and 200mg tablets are also available, plus an initiation pack containing 12.5mg and 25mg tablets [15-17].
Jun 21Approved in UK for adjunctive treatment of focal-onset seizures, with or without secondary generalisation [14].
Apr 21Approved in EU [13].
Jan 21Recommended for EU approval by CHMP - the full indication is "for the adjunctive treatment of focal-onset seizures with or without secondary generalisation in adult patients with epilepsy who have not been adequately controlled despite a history of treatment with at least 2 anti-epileptic medicinal products" [12]
May 20SK Biopharmaceuticals launches cenobamate tablets, under the brand name X-Copri and XCOPRI, for the treatment of partial-onset seizures in adult patients in the US [11].
Mar 20EMA accepts Arvelle Therapeutics´ MAA for cenobamate for the adjunctive treatment of focal-onset seizures in adults[10].
Nov 19Approved in US, wth plans to file in the EU in the first half of 2020 [9].
Nov 19Once approved by the EMA, the drug is intended to be launched in 32 European countries including Britain, Germany, France and Switzerland [8].
Nov 19Arvelle Therapeutics plan to file NDA in EU H1 2020 [7].
Feb 19SK Biopharmaceuticals and Arvelle Therapeutics announce agreement to develop and commercialise cenobamate in Europe [7].
Feb 19SK life science announces FDA acceptance of NDA submission for cenobamate, with PDUFA date set for 21/11/19 [6].
Nov 18SK Biopharmaceuticals is seeking partners for the development of cenobamate [4].
Category
A sodium channel blocker, with a binding site different from that of classical sodium channel blocking drugs and it enhances GABAergic transmission by increasing presynaptic GABA release.
Incidence is estimated to be 50 per 100,000 per year and the prevalence of active epilepsy in the UK is estimated to be 5–10 cases per 1000 [1].
Partial focal epilepsy - adjunctive therapy
Oral
Further information
Yes
Trial or other data
Nov 19Results of PII (NCT01866111) study are published in The Lancet Neurology. RCT (n=437) found adjunctive cenobamate reduced 28 day focal (partial)-onset seizure frequency, in dose-related fashion (median change:−24.0% placebo vs. −35.5% (p=0.0071) 100mg, −55.0% (p<0.0001) 200mg and −55.0% (p<0.0001) 400mg group. ADRs were most frequent with highest dose [5].
Nov 18PIII study (NCT02535091) record not updated since Jun 17 [3].
Jun 17PIII study (NCT02535091) still recruiting [2].
Jun 16PIII study to to assess the safety and pharmacokinetics of YKP3089 as adjunctive therapy in subjects with partial onset seizures starts (NCT02535091). Initially, subjects taking phenytoin or phenobarbital will be enrolled followed by additional subjects taking anti-epileptic drugs other than phenytoin and phenobarbital to further investigate long-term safety. 1,200 patients will be recruited in several countries including US & EU (not UK). Collection of primary outcome data is due to complete Jun 18 [2].
Evidence based evaluations
Ontozry (EU), Xcopri (US) Primary generalised tonic-clonic epileptic seizures - adjunctive therapy
Information
Ontozry (EU), Xcopri (US)
Licence extension / variation
Arvelle Therapeutics
SK Bio-Pharmaceuticals
Development and Regulatory status
None
Phase III Clinical Trials
Phase III Clinical Trials
Category
A sodium channel blocker, with a binding site different from that of classical sodium channel blocking drugs and it enhances GABAergic transmission by increasing presynaptic GABA release.
Prevalence of active epilepsy is 5-10 cases per 1,000 (with 5-30% of these misdiagnosed as having epilepsy). A systematic review and meta-analysis of international studies found a point prevalence of epilepsy of 6.38 per 1,000 people and lifetime prevalence of 7.60 per 1,000 people [1].
Primary generalised tonic-clonic epileptic seizures - adjunctive therapy
Oral