Eisai’s Fycompa (perampanel) Receives EC’s Approval for Expanded Indication in Pediatric Patients with POS and PGTCS

November 16, 2020 Auto Bot receives, regulatory 0

Shots:

  • The approval extends the use of Fycompa as adjunctive therapy for POS (with/out secondary generalization) by expanding the approved age range from 12yrs.+ to 4yrs.+ and for PGTCS from 12yrs.+ to 7yrs.+
  • The approval is based on P-III 311 study assessing Fycompa (oral suspension) as adjunctive therapy in 180 pediatric patients (aged 4-12 yrs.) with POS or PGTCS
  • The 232 study involves assessing the PK, efficacy, and long-term safety of Fycompa taken at the same time as other AEDs therapy in 63 pediatric patients with epilepsy in patients aged 2 to >12yrs. Fycompa is an AMPA receptor antagonist that reduces neuronal hyperexcitation associated with seizures

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