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<figure class="wp-block-image"><img src="https://sidikkanali.az/wp-content/uploads/2019/11/thinkstockphotos-186964533.jpg" alt="" class="wp-image-586"/><figcaption>Mind control The US Food and Drug Administration (FDA) has given Arvelle Therapeutics’ Xcopri (cenobamate tablets) the go-ahead for partial-onset seizures in adults. </figcaption></figure>
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<p>The emerging company, which is part of a subsidiary of SK Biopharmaceuticals, announced that it has also licensed exclusive rights to develop and commercialise the drug in Europe, with intent to file a Marketing Authorisation Application (MAA) in the first half of next year, based on Phase II and III trials.</p>
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<p>The FDA approval was based on the same studies, which demonstrated a significant reduction in seizure frequency at all doses studied compared to placebo. Study 013 and 017 showed a statistically significant 56% reduction from baseline in seizure frequency and statistically significant responder rates in all doses, respectively.</p>
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<p>The FDA approval has been hailed as a “critical step forward in our efforts to bring this important potential medicine to Europe” explained Mark Altmeyer, president and chief executive officer of Arvelle.</p>
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<p>He went on to say “We believe cenobamate could potentially be a welcome new treatment option for people living with this debilitating condition.”</p>
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<p>There are currently an estimated six million people in Europe with epilepsy, and approximately 40% of adult patients with epilepsy have inadequate control of seizures after treatment with two AED regimens.</p>
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