Keppra(R) Approved for US Epilepsy Patients with One of the Most Debilitating Seizure Types
- Category: Small Molecules
- Published on Wednesday, 21 March 2007 02:00
- Hits: 1881
BRUSSELS, Belgium | Mar 20, 2007 | 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<0.001). Keppra(R) was well- tolerated, and nasopharyngitis was the most commonly reported adverse effect (14% in Keppra(R) patients compared with 5% in patients receiving placebo).
"People with epilepsy want to be free to get on with their everyday lives. We are pleased that there is now an opportunity for patients with one of the most debilitating seizure types -- primary generalized tonic-clonic seizures - - to benefit from Keppra(R)," said Troy Cox, President CNS Operations, UCB. "This latest indication for Keppra(R) supports its broad spectrum of efficacy across partial and generalized seizures types."
Keppra(R) was approved by the FDA in 1999 as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy. Since 1999, Keppra(R) has received several supplemental indications as adjunctive therapy for epilepsy, making it one of the few treatments approved to treat seizure types that together account for more than 80 percent of all seizures. These FDA indications include:
-- Partial onset seizures in patients 4 years of age and older with epilepsy
-- Myoclonic seizures in patients 12 years of age and older with Juvenile Myoclonic Epilepsy (JME)
-- Keppra(R) intravenous formulation for partial seizures as an alternative for adult patients when oral administration is temporarily not feasible
-- Primary Generalized Tonic-Clonic (PGTC) seizures in patients 6 years of age and older with idiopathic generalized epilepsy
This U.S. approval closely follows the European Commission approval for Keppra(R) in this debilitating generalized seizure type earlier this year.
About Keppra(R) in the U.S.
Keppra(R) is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy, myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy, and primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.
Keppra(R) injection is indicated as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy. Keppra(R) injection is an alternative for patients when oral administration is temporarily not feasible.
Keppra(R) tablets and oral solution are associated with the occurrence of central nervous system adverse events including somnolence and fatigue, behavioral abnormalities, and coordination difficulties, as well as hematological abnormalities. In pediatric patients 4-16 years of age experiencing partial onset seizures, the most common adverse events associated with Keppra(R) in combination with other AEDs were somnolence, accidental injury, hostility, nervousness and asthenia. In adults experiencing partial onset seizures, the most common adverse events associated with Keppra(R) in combination with other AEDs were somnolence, asthenia, infection and dizziness. In patients 12 years of age and older with juvenile myoclonic epilepsy, the most common adverse events associated with Keppra(R) in combination with other AEDs were somnolence, neck pain, and pharyngitis. In patients 6 years of age and older with idiopathic generalized epilepsy, the most common adverse event associated with Keppra(R) in combination with other AEDs was nasopharyngitis.
The adverse events that result from Keppra(R) injection use for partial onset seizures include all of those associated with Keppra(R) tablets and oral solution.
UCB (http://www.ucb-group.com) is a leading global biopharmaceutical company dedicated to the research, development and commercialization of innovative pharmaceutical and biotechnology products in the fields of central nervous system disorders, allergy/respiratory diseases, immune and inflammatory disorders and oncology. UCB focuses on securing a leading position in severe disease categories. Employing over 8,300 people in over 40 countries, UCB achieved revenue of 2.3 billion euro in 2005. UCB is listed on the Euronext Brussels Exchange. Worldwide headquarters are located in Brussels, Belgium.