Epilepsy drug now available for tonic-clonic seizures

Fycompa, a once-daily epilepsy treatment from Eisai, is now available in Australia for adjunctive treatment of primary generalised tonic-clonic (PGTC) seizures in adults and adolescents (≥12 years) with idiopathic generalised epilepsy. The milestone comes two years after the drug was initially made available in Australia for the adjunctive treatment of partial-onset seizures, with or without secondarily generalised seizures.

It is estimated that idiopathic generalised epilepsy makes up 20% of all epilepsies, with PGTC seizures being the most common seizure type. Such seizures start with a loss of consciousness and a sudden contraction of the muscles, which can cause the person to fall down (tonic phase), followed by violent seizures (clonic phase) until the muscles finally relax. There is a serious risk of injury with PGTC seizures, including bone fractures and burns.

The number of anti-epileptic drugs licensed for the treatment of PGTC seizures is limited, and up to 20% of people with idiopathic generalised epilepsy remain uncontrolled despite treatment. Fycompa’s approval for PFTC indication is therefore “a welcome advance for people living with idiopathic generalised epilepsy who experience tonic-clonic seizures”, according to John Bower, market access and medical director of Eisai Australia.

The approval follows a Phase III randomised, double-blind, placebo-controlled study in which 164 patients age 12 years or older taking 1–3 anti-epileptic drugs with PGTC seizures and IGE were randomised to receive adjunctive Fycompa (8 mg/d or highest tolerated dose) or a placebo. Fycompa subjects achieved a ≥50% reduction in PGTC seizure frequency compared with placebo (64.2% vs 39.5%, respectively). The drug also showed a greater median percent reduction in PGTC seizure frequency per 28 days compared with placebo (76.5% vs 38.4%). Furthermore, 31% of patients were PGTC seizure-free during the 13-week maintenance period when treated with Fycompa as an adjunctive therapy, compared to 12% in the placebo group.

“Approval for our first-in-class treatment Fycompa in the PGTC indication is a positive step, building on the medicine’s availability in focal seizures,” said Jaime McCoy, country POA, sales and marketing director, Eisai, Australia. “Importantly, it also evidences Eisai’s human healthcare mission, including our commitment to epilepsy and to improving outcomes for the many Australians living with this disease and their families.”