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Fycompa

FDA Expands Use of Epilepsy Drug Perampanel (Fycompa) to Younger Children

The US Food and Drug Administration (FDA) has granted expanded approval of perampanel (Fycompa, Esai Inc) for the treatment of “partial-onset seizures (POS) with or without secondary generalized seizures” in patients as young as 4 years, the manufacturer reports. The expanded indication is for both monotherapy and adjunctive use in patients 4 years of age and older. The drug was initially approved in 2012 as adjunctive treatment for POS. This was followed in 2015 by approval as adjunctive treatment for primary generalized tonic-clonic seizures in patients with epilepsy who were at least 12 years of age, and in 2017 as monotherapy for POS with or without secondary generalized seizures in the same age group. To date, the drug “is approved in 55 countries and has treated mor...

Perampanel for epilepsy: Still no proof of added benefit

Fycompa has not been approved by the FDA as an add-on therapy for seizures because additional benefit has yet to be proven. From MedicalXpress: The drug perampanel (trade name Fycompa) has been approved since July 2012 as adjunctive (“add-on”) therapy for adults and children aged 12 years and older with epileptic fits (seizures). In a new early benefit assessment according to the Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether perampanel offers an added benefit over the appropriate comparator therapy. However, such an added benefit cannot be derived from the new dossier either, as the drug manufacturer did not submit any relevant data for this comparison. Already in the first...