New drug for epilepsy! EU CHMP recommends approval of Xcopri (cenobamate): complementary treatment of adult eclampsia epilepsy!

Epilepsy (Photo source: biospace.com) January 31, 2021 // -- Arvelle Therapeutics is an emerging biopharmaceutical company dedicated to developing innovative therapies for patients with central nervous system (CNS) diseases.
recently, the company announced that the European Medicines Agency (EMA) Human Pharmaceutical Products Committee (CHMP) has issued an active review recommending the approval of Xcopri (cenobamate), an anti-epileptic drug (AED) for adult patients with epilepsy who have previously been treated with at least two anti-epileptic drugs (ASM) but have not been adequately controlled, to assist in the treatment of developed seizures (accompanied or not accompanied by systemic seizures).
chMP's comments will now be submitted to the European Commission, which is expected to make a final review decision within two months.
estimated that there are 6 million people with epilepsy in Europe, about 40 per cent of adult epilepsy patients are under-controlled after receiving treatment with two anti-epileptic drugs (ASM).
In 2 well-controlled clinical studies, Xcopri significantly reduced the frequency of seizures during recurrent seizures compared to placebos, and achieved zero seizures in up to 20% of patients during the maintenance period.
, Xcopri was approved in November 2019 for adult treatment of partial seizure epilepsy.
was discovered and developed by SK Biopharmaceuticals of Korea and its US subsidiary SK Life Sciences.
2019, SK Biopharmaceuticals signed an exclusive license agreement with Marvel Therapeutics GmbH to develop and commercialize the drug in Europe.
January 2021, Angelini Pharma announced an acquisition agreement with Marvel Therapeutics.
, Arvelle will have an exclusive license to commercialize Xcopri in other countries of the European Union and the European Economic Area.
plans to bring Xcopri to market in the second quarter of 2021, after euthan approval.
positive opinion of CHMP, based on 3 clinical trials involving more than 1,900 patients.
Main Trial (Study 017), published in The Lancet Neurology, a multi-center, double-blind, randomized, placebo-controlled trial, confirmed that Xprico is an effective treatment option for adult patients with uncontrolled eclampsia with 1-3 anti-epileptic drugs (ASM).
the 12-week maintenance period, all doses of Xcopri showed significantly higher response rates (≥50 percent lower frequency of seizures≥ compared to placebo.
response rates were 40% (p-0.036), 56% (p-lt;0.001), 64% (p-lt;0.001), and 25% in the placebo group, respectively, in the 100mg/day, 200mg/day, 400mg/day group.
addition, 4% of patients treated with 100mg, 200mg and 400mg Xcopri during the maintenance period (no significant difference, p=0.369), 11% The frequency of seizures (100% seizure-free) decreased by 100% (p-0.002) and 21% (p-lt;0.001), compared with 1% in the placebo group.
cenobamate molecular structure (Photo: mechemexpress.cn) In Europe, about 6 million people suffer from epilepsy, and about 40 percent of adults have eclampsia, which persists even after using two types of AED treatment, highlighting the need for new treatment options.
seizures are usually short-lived abnormal electrical activity in the brain that can lead to uncontrolled movement, abnormal thinking or behavior, and abnormal sensations.
can be intense and the patient may lose consciousness.
onset seizures begins in a limited area of the brain.
Xcopri's active pharmaceutical ingredient is cenobamate, a sodium ion channel blocker.
The exact mechanism by which Xcopri plays a therapeutic role is not yet known, but SK Biopharmaceuticals believes the drug, which is also a positive-variant regulator of the γ-amino butyric acid (GABAA) ion channel, reduces repetitive neuron discharge by suppressing voltage-gateed sodium currents.
, Xcopri is available in the U.S. and has six dose strengths: 12.5mg, 25mg, 50mg, 100mg, 200mg.
medication, Xcopri should start at 12.5 mg once a day and be titred every 2 weeks.
after the drug adjustment period, the recommended maintenance dose is 200 mg/day, but some patients may need to adjust to 400 mg/day, which is the maximum recommended dose.
Xcopri can be used in union with other anti-epileptic drugs or alone.
() Original origin: ONTOZRY (cenobamate) receives positive CHMP opinion for the adjunctive treatment of of uncontrolled focal onsets in adults