SK Biopharm Submits Phase 3 Clinical Trial Plan for Lennox-Gastaut Syndrome Treatment to US FDA
[Asia Economy Reporter Minwoo Lee] SK Biopharm announced on the 6th that it has submitted the clinical trial protocol for Carisbamate (YKP509), a treatment for Lennox-Gastaut syndrome, to the U.S. Food and Drug Administration (FDA).
Through this clinical trial, the efficacy and safety of Carisbamate will be evaluated in pediatric and adult patients diagnosed with Lennox-Gastaut syndrome. The trial will involve approximately 250 patients and will be conducted over 75 weeks at more than 60 hospitals in the United States and other countries.
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The company stated, "If the drug development is successful, it will expand the treatment options for the rare disease Lennox-Gastaut syndrome and contribute to improving patients' quality of life."
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