Keppra gets FDA OK as PGCT seizure therapy

Belgian drugmaker UCB says that its anti-epileptic Keppra (levetiracetam) has been approved by the US Food and Drug Administration as an adjunctive therapy for primary generalized tonic-clonic seizures in patients suffering idiopathic generalized epilepsy. The decision, which marks the fourth indication for which the drug has been cleared in the USA, follows a similar ruling by European regulators earlier this year (Marketletter January 22).

The FDA's approval, which specifies that Keppra can be used to treat adults and children six years old and over, is based on data from a trial that examined the agent as an add-on therapy in 164 refractory IGE sufferers. The results showed that the drug conferred complete seizure prevention in 24.1% of patients, for the entirety of the 20-week study, compared with only 8.3% of the placebo group.

In addition, 72.2% of those who received Keppra achieved a 50% reduction in the occurrence of PGCT seizures, whereas only 45.2% of the control group saw such improvement. The most frequently reported adverse event was nasopharyngitis, which occurred in 14% of those in the treatment group, and 5% of the placebo cohort.