Leading the Way in Life Science Technologies

GEN Exclusives

More »

GEN News Highlights

More »
October 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. 

Related content

  • Finally! A cure for the Biotech News Blues.

  • Join 110,000 colleagues who rely on GEN Highlights for breaking news and exclusive articles shaping today’s life science tools and technologies.

  • Oops! Please type your email in the following format: yourname@example.com An error has occurred. Please contact Customer Service at contactGEN@genengnews.com
  • You’re all set! Thank you for subscribing to GEN Highlights.