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FDA clears SK Life Science’s anti-epileptic drug Xcopri

Significantly reduced the frequency of seizures at all doses studied

FDA US headquarters

Korea-based SK Life Sciences has scored approval from the FDA in the US for its anti-epileptic drug Xcopri, as a treatment for partial-onset seizures in adults. 

The approval is based on results from two phase 3 studies, which investigated the treatment in adults with uncontrolled partial-onset seizures, who were taking one to three concomitant anti-epileptic drugs.

The results from these studies – Study 013 and Study 017 – showed that Xcopri (cenobamate) significantly reduced the frequency of seizures compared to placebo at all doses studied.

According to SK, the FDA nod for Xcopri is the first time a Korean company has independently developed a compound from discovery to approval in the US.

The safety profile of the anti-epilepsy drug does include side effects – Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) was reported among patients taking Xcopri.

In the clinical trials, a number of patients experienced DRESS, with one patient dying, as a result of Xcopri being titrated rapidly (weekly or faster titration).

However, no cases of DRESS were reported in a safety study of 1,339 epilepsy patients with Xcorpi started at 12.5mg per day and adjusted every two weeks. According to the FDA, this finding does not show however that the risk of DRESS is prevented by slower titration.

“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,” said Jeong Woo Cho, president and CEO of SK Biopharmaceuticals and SK life science.

“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,” he added.

New medications for epilepsy are pivotal, as seizures can cause abnormal thinking or behaviour, and abnormal sensations.

Another recent treatment development for the number of conditions which cause seizures, which range in severity, has been the steady approvals of cannabidiol (CBD) based medicines.

This includes GW Pharma’s Epidyolex, which is the first medicine based on a highly-purified, plant derived CBD, which lacks the high associated with cannabis or marijuana.

It its approved for seizures in patients aged two or over with Lennox-Gastaut syndrome (LGS) or Dravet syndrome, in conjunction with clobazam. These two syndromes are rare but extreme debilitating forms of epilepsy, typically causing multiple seizures per day, and are both considered to be hard to treat.

Article by
Lucy Parsons

22nd November 2019

From: Regulatory

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