XCOPRI FDA approval : SK Biopharmaceuticals said that its US subsidiary SK Life Science has been granted approval from the US Food and Drug Administration (FDA) for its anti-epileptic drug XCOPRI (cenobamate tablets) for the treatment for partial-onset seizures in adults.
According to the FDA, a seizure is normally a short episode of abnormal electrical activity that takes place in the brain. Seizures can lead to uncontrolled movements, abnormal thinking or behavior, and also abnormal sensations.
Movements of the person having a seizure can turn violent, and changes in consciousness can happen. The FDA says that seizures are caused by the uncontrolled activation of clusters of nerve cells in the brain. A partial-onset seizure starts in a limited area of the brain, as per the FDA.
XCOPRI is said to cut down repetitive neuronal firing by inhibiting voltage-gated sodium currents. The anti-epileptic drug is also a positive allosteric modulator of the γ‑aminobutyric acid (GABAA) ion channel.
Beth Lewin Dean – CEO of Citizens United for Research in Epilepsy (CURE), commenting on XCOPRI FDA approval, said: “Approximately 3 million adults live with epilepsy in the U.S. and according to the Centers for Disease Control and Prevention (CDC), nearly 60% reported having seizures, even if they took an AED.
“There is an urgent need to advance research and introduce new treatment options. The FDA approval of XCOPRI for the treatment of partial-onset seizures is a welcome option for the epilepsy community.”
XCOPRI FDA approval has been driven by the findings of a couple of global, randomized, double-blind, placebo-controlled trials – Study 013 and Study 017 and a global, multi-center, open-label safety study that had adults having uncontrolled partial-onset seizures, taking one to three concomitant anti-epileptic drug (AEDs).
In Study 013 and Study 017, XCOPRI could show substantial reductions in seizure frequency in comparison to placebo at all the studied doses.
The approval of XCOPRI marks the first time a South Korean pharma company has independently brought a compound from discovery stage to the desired FDA decision.
Commenting on XCOPRI FDA approval, Jeong Woo Cho – President and CEO of SK Biopharmaceuticals and SK Life Science, said: “Today’s approval is a major step toward our goal of becoming a fully-integrated global pharmaceutical company that can discover, develop and deliver new treatment options in epilepsy and CNS.
“We are grateful to the thousands of participants in our trials, clinical investigators, partners in the epilepsy community and our employees for their important contributions in bringing forward this treatment option for adults with partial-onset seizures.”
XCOPRI is likely to be available from Q2 2020, subject to review by the US Drug Enforcement Administration (DEA). Earlier this year, SK Biopharmaceuticals signed exclusive licensing agreement with Arvelle Therapeutics to develop and commercialize the anti-epileptic drug in Europe.
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