AsianScientist (Oct. 17, 2018) – Japanese drugmaker Eisai has received approval from the US Food and Drug Administration (FDA) to use its antiepileptic drug Fycompa for the treatment of partial-onset seizures in pediatric patients four years of age and older. Fycompa was designated for priority review by the FDA and approved approximately six months after submission.
Epilepsy affects approximately 3.4 million people (approximately 470,000 children and three million adults) in the US. While epilepsy affects people of all ages, the condition is particularly common among children and the elderly. As approximately 30 percent of patients with epilepsy are unable to control their seizures with currently available antiepileptic drugs, this is a disease with significant unmet medical need.
Discovered at Eisai’s Tsukuba Research Laboratories in Japan, Fycompa is a highly selective molecule that reduces neuronal hyperexcitation associated with seizures. It is available in tablet and oral suspension form.
The latest approval for the drug was based on the interim results of a Phase III multicenter clinical study wherein patients showed improvements after a 23-week treatment phase in which they received 2-16 mg of Fycompa orally once a day. The long-term safety of Fycompa consumption was also assessed during an extension phase. The most common adverse events observed in the study were drowsiness, nasal inflammation, dizziness and irritability.
Similarly optimistic results were reported from a separate Phase II clinical study. Collectively, both studies confirmed that the safety and efficacy of Fycompa were similar between adult and pediatric patients.
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Source: Eisai; Photo: Pexels.
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