UCB: Keppra XR(TM) approved in the U.S.
UCB: Keppra XR(TM) approved in the U.S.
* As adjunctive therapy, Keppra XR(TM) offers significant partial onset seizure reduction, proven tolerability, and once-daily dosing * Keppra XR(TM) is built on a trusted heritage
Brussels, BELGIUM - September 15, 2008 at 7:00 am CEST - pressrelease, regulated information: UCB announced today that the U.S.Food and Drug Administration (FDA) has approved Keppra XR(TM)(levetiracetam extended-release tablets) for use as an add-on toother antiepileptic treatments for people with partial onset seizureswho are 16 years of age and older. Keppra XR(TM) is expected to beavailable in U.S. pharmacies at the end of September 2008.
The goal of therapy with antiepileptic drugs (AEDs) is freedom fromseizures and minimal side effects. While many people with epilepsyare successfully treated with one or more of the currently availableAEDs, a significant percentage still live with uncontrolled seizuresor intolerable side effects.
"With solid clinical trial data supporting Keppra XR(TM) efficacy andtolerability, this once-daily antiepileptic drug can play animportant role in treating people with epilepsy," said leadinvestigator Dr. Jukka Peltola, Department of Neurology, TampereUniversity Hospital, Finland. "We found in the clinical trial thatKeppra XR(TM) provided significant partial onset seizure control inonce-daily dosing when added to other antiepileptic drugs and that itwas generally well-tolerated."
Building On A Trusted Heritage
"This is one of many milestones at UCB to develop new treatmentoptions for people with epilepsy," said Troy Cox, Senior VicePresident UCB & President CNS Operations. "Keppra XR(TM) provides away to simplify treatment and offers another chance to achieveseizure control, which is an important goal for patients living withepilepsy."
The immediate release tablet form of Keppra® (levetiracetam) wasfirst approved by the FDA in 1999 as adjunctive therapy in thetreatment of partial onset seizures in adults with epilepsy. Sincethen, Keppra® has become a leading antiepileptic drug in the U.S.
Important Safety Information
Keppra XR(TM) extended release tablets are indicated as adjunctivetherapy in the treatment of partial onset seizures in patients 16years of age and older with epilepsy.Keppra XR(TM) causes somnolence, dizziness, and behaviouralabnormalities. The most common adverse reactions observed withKeppra XR(TM) combination with other AEDs were somnolence andirritability.The adverse reactions that may be seen in patients receivingKeppra XR(TM) are expected to be similar to those seen in patientsreceiving immediate-release Keppra® tablets.
Keppra® immediate-release tablets cause somnolence and fatigue,coordination difficulties, and behavioural abnormalities (e.g.,psychotic symptoms, suicidal ideation, and other abnormalities) aswell as hematological abnormalities. In adults experiencing partialonset seizures, the most common adverse reactions observed withKeppra® in combination with other AEDs were somnolence, asthenia,infection and dizziness.
Keppra XR(TM) should be gradually withdrawn to minimize the potentialof increased seizure frequency.
Dosing must be individualized according to the patient's renalfunction state. The dosage should be reduced in patients withimpaired renal function receiving Keppra XR(TM). In patients with endstage renal disease on dialysis, it is recommended thatimmediate-release Keppra® be used instead of Keppra XRTM.
For full prescribing information, please see www.KeppraXR.com.
In order to ensure patient access to this valuable medication in theU.S., UCB is initiating a co-pay support program. For moreinformation, contact the U.S. UCB Medical Information at1-866-822-0068 (press 9).
About Epilepsy
Epilepsy is a chronic neurological disorder affecting approximatelythree million people in the U.S.-making it more common than multiplesclerosis and Parkinson's disease combined. It is caused by abnormal,excessive electrical discharges of the nerve cells, or neurons, inthe brain. Epilepsy is characterized by a tendency to have recurrentseizures and defined by two or more unprovoked seizures. There aremany different seizure types and epileptic syndromes. 40 % ofpatients taking only one AED continue to experience seizures, andapproximately 30% of patients taking adjunctive therapy continue toexperience seizures. This highlights the ongoing need for thedevelopment of new AEDs. For more information about epilepsy, visitwww.epilepsyfoundation.org, www.epilepsy.com, orwww.epilepsyadvocate.com.
Further informationAntje Witte, Vice-President Corporate Communications & InvestorRelations, UCB GroupT +32.2.559.9414, Antje.witte@ucb-group.comEimear O'Brien, Global CNS Communications Manager, UCB GroupT +32.2.559.9271, Eimear.OBrien@ucb-group.comAndrea Levin, Public Relations Manager, CNS, UCB U.S.T +1.770.970.8352, Andrea.levin@ucb-group.com
About UCB
UCB, Brussels, Belgium (www.ucb-group.com) is a global leader in thebiopharmaceutical industry dedicated to the research, development andcommercialisation of innovative medicines with a focus on the fieldsof central nervous system and immunology disorders. Employing around12 000 people in over 40 countries, UCB achieved revenue of 3.6billion euro in 2007. UCB is listed on Euronext Brussels (symbol:UCB).
Forward looking statement
This press release contains forward-looking statements based oncurrent plans, estimates and beliefs of management. Such statementsare subject to risks and uncertainties that may cause actual resultsto be materially different from those that may be implied by suchforward-looking statements contained in this press release. Importantfactors that could result in such differences include: changes ingeneral economic, business and competitive conditions, effects offuture judicial decisions, changes in regulation, exchange ratefluctuations and hiring and retention of employees.
