New Treatment Option For Epilepsy Patients With One Of The Most Debilitating Seizure Types
The U.S. Food and Drug Administration (FDA) yesterday approved UCB's leading anti-epileptic drug Keppra(R) (levetiracetam) tablets and oral solution as adjunctive therapy in the treatment of primary generalized tonic-clonic (PGTC) seizures in patients 6 years of age and older.
"Almost one in four people with epilepsy have tonic-clonic seizures, which are one of the most recognizable seizure types beginning with a sudden loss of consciousness and stiffening of the muscles, followed by rapid rhythmic jerking of the arms and legs," said Robert C. Knowlton, MD, Associate Professor of Neurology, University of Alabama at Birmingham. "Seizure freedom with minimal side effects is the ultimate goal for physicians and patients. The results of the trial supporting this new indication demonstrate the growing evidence for Keppra(R) as an effective adjunctive therapy across partial and generalized seizure types."
In a well-controlled clinical trial of Keppra(R) as add-on treatment in 164 patients (ages 4-65) with refractory idiopathic generalized epilepsy (IGE), nearly a quarter (24.1%) achieved complete seizure freedom from all seizure types over the 20-week evaluation period, compared with only 8.3 percent of those who received a placebo in addition to their usual treatment (p=0.009). Nearly three quarters (72.2%) of those who took Keppra(R) achieved a 50 percent reduction in weekly PGTC seizures, compared with less than half (45.2%) of those in the placebo group (p