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The US Food and Drug Administration (FDA) has approved the use of the perampanel antiepileptic drug (FYCOMPA) CIII as monotherapy and adjunctive therapy in pediatric patients for the treatment of partial seizures.
The therapy, from Eisai Inc., has been approved for patients 4 years of age and older, who have POS with or without generalized secondary seizures, both as a tablet and oral suspension formulation. In the United States, approximately 470,000 children currently live with epilepsy and nearly half of them will fail to free themselves from seizures with their existing treatments.
The indication of Perampel in pediatric patients with epilepsy was corroborated by the efficacy results of three phase 3 clinical trials in adult patients with SOP. Its safety has also been evaluated in a pair of studies in pediatric patients with epilepsy, in which 225 patients in total received perampel – 110 at least 6 months and 21 at least 1 year.
The end results of these studies supporting the approvals should be presented at an upcoming medical meeting, according to Eisai. Perampanel is a noncompetitive selective AMPA receptor agonist that exerts antiepileptic effects by a clinically unknown mechanism.
As a once-daily dosing option with an extended half-life, perampanel becomes a viable treatment option for pediatric patients. Lynn Kramer, MD, Head of Clinical Services and Chief Medical Officer of Eisai Neurology Business Group, said that Eisai's "tireless" work to provide treatment options for all ages in crisis control and of general freedom.
"We are excited about the potential of FYCOMPA as an important tool to reduce the incidence of seizures in pediatric patients living with epilepsy," Kramer said. "This milestone underscores our commitment to providing treatment options to children with epilepsy for whom there is still a significant unmet need."
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