Eisai files Fycompa at EMA and FDA for uncontrolled primary generalized tonic-clonic seizures

Eisai has filed its anti-epileptic Fycompa (perampanel) for use as an adjunctive therapy in people with uncontrolled primary generalized Tonic-Clonic Seizures (PGTC), an additional indication, in the US and EU. The filing is based on the results of the Phase III Study 332 of 164 people over 12 years old with refractory PGTC seizures, despite treatment with one to three concomitant anti-epileptic drugs. Perampanel significantly reduced PGTC seizure frequency (the primary indication for US approval) and improved responder rates (greater than or equal to 50% reduction in seizure frequency per 28 days in the maintenance period, relative to baseline – the primary analysis in the EU), compared with placebo.