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GEN News Highlights : Oct 23, 2012

FDA Clears Eisai’s Epilepsy Drug Fycompa

FDA approved Eisai’s epilepsy drug Fycompa (perampanel) as an adjunctive treatment for partial-onset seizures with or without secondarily generalized seizures in patients aged 12 and over. The firm says Fycompa is the first FDA-approved non-competitive AMPA (alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid) glutamate receptor agonist. The drug was approved in the EU in July.

Regulatory clearance in the U.S. was based on data from three Phase III placebo-controlled studies evaluating the efficacy and safety of perampanel when administered as an adjunctive therapy in patients aged 12 years and over with partial-onset seizures.

FDA has recommended Fycompa is classified as a scheduled drug by the Drug Enforcement Administration, which will determine the final scheduling designation, prior to Eisai’s launch of the drug.