SK Biopharmaceuticals' XCOPRI, a treatment for partial-onset seizures in adults, has become the Korean drug to win the U.S. Food and Drug Administration’s approval independently, without partnering or licensing out to other multinational pharmaceutical companies.
The drug, which had been developed since 2001, treats people with epilepsy but are not responsive to conventionally approved treatments.
The FDA based its approval on results from two global studies that enrolled adults with uncontrolled partial-onset seizures, taking one to three concomitant antiepileptic drugs (AEDs).
In the randomized studies, XCOPRI demonstrated significant reductions in seizure frequency compared to placebo at all doses studied.
"The approval of XCOPRI will provide clinicians with an effective medication treating patients who continue to have focal (partial-onset) seizures," said Professor Michael Sperling, an investigator in the XCOPRI clinical development program. "It is very encouraging to see that patients taking XCOPRI saw significant reductions in the frequency of seizures, with some even achieving zero seizures."
Billy Dunn, director of the Office of Neuroscience in the FDA's Center for Drug Evaluation and Research, also said, "XCOPRI is a new option to treat adults with partial-onset seizures, which is an often difficult-to-control condition that can have a significant impact on patient quality of life. Patients can have different responses to the various seizure medicines that are available."
This approval provides an additional treatment option for people with this condition, Dunn added.
According to the company, XCOPRI is expected to be available in the U.S. in the second quarter of 2020, following a scheduling review by the U.S. Drug Enforcement Administration (DEA), which typically occurs within 90 days of FDA approval. SK Life Science will lead the marketing and sales of the drug in the U.S.
SK Life Science plans to introduce a new access program to help patients get started and stay on track with their medicine.
"Today's approval is a major step toward our goal of becoming a fully integrated global pharmaceutical company that can discover, develop, and delivers new treatment options in epilepsy and CNS," SK Biopharmaceuticals CEO Cho Jeong-woo said.
The company is grateful to the thousands of participants in the trials, clinical investigators, partners in the epilepsy community, and employees for their important contributions to bringing forward this treatment option for adults with partial-onset seizures, Cho added.